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Abstract—Functional electricalstimulationis a therapy based
procedure where muscles are activated via electrical signals to
target stimulation of lost connection between the CNS andmotor
neurons. During FES application, patients are retaught basic
movements and functions through the use of ergometers or
simple therapy instructions. Loss of muscularcontrol and
peripheral nerve damage are the basic reasons for needof
biopotential feedback . Often, in patients with SCI, use of EEG is
an effective way to track electrical activity in the brain whilst
movements are done. Lack of a neural system to efficiently
translate messages to extremities foraction can qualify an
individual for both FES and BCI interaction. Thus, EEG is often
usedin conjunction with BCI to get a biopotential feedback for
control systems with SCIor paralysis patients. BCI-FES systems
that are monitored with helpof EEG feedback have proven to be
helpful in restoration of motor control, and compared to EMG
feedback, and often proves as being more reliable. [2] However,
in many FES studies, a phenomenon known as the carryover
effect has been recorded to take place. This effect is when
patients regain the ability to complete motor tasks after stroke or
SCI, thought to be triggeredfrom FES and rehabilitation of
muscle memory. However, the period of time where carryover is
present and initiates is unknown. This experiment is designedto
see if there is a correlation between FES therapy time and
duration of carry-over persisting or occurring in a patient. Foot
drop patients were grouped into 3 sub groups all with varying
time periods of applied therapy, ranging from 6 months to 1 year.
The FES system was made up of an EEG-BCI interface
connectedto a feedback loop to allow stimulation of the peroneal
nerve. A capacity score based algorithm on how much
improvement within a time frame occurred as a result of
carryover was usedto detect the phenomenon.
I. INTRODUCTION
Functional electrical stimulation aids to help patients recover
movement of lost extremity control from stroke or SCI,
especially when administered over a long time period with
frequent therapy sessions.Both duration of stimulation and
type are large factors in the determination of neural plasticity
producing the carryover effect in a patient.
5/4/16. This work was supported by the UB Biomedical Engineering
Department.
Emily Koehler, Biomedical Engineering undergraduate, University at
Buffalo. emilykoe@buffalo.edu
However, the carryover effect has no true trigger, therefore
its classification of occurring can vary. We are still unsure
of when FES ends and voluntary control takes over. If this
range of time was found,then therapeutic stimulation to
those with SCI and stroke could be narrowed down to a
specific range to allow patients to potentially see and be
somewhat guaranteed (based on therapy sessions)some sort
of control of lost muscle mass again. These time frames can
be tested and applied on different types oftrauma to
broaden our understanding of cortical remapping. FES
systems and clinical therapy would be able to modify
current procedures in rehabilitation to allow for a window
of maximal time where carryover can be initiated.
II. BACKGROUND
A. Spinal Cord Injury
The spinal cord is the site of motor and sensory stimulation
passing through the central nervous systemand the rest of the
human body. According to the NSCSC, there are near 12,500
new SCI injuries per year in the United States,with an average
age of 42. [1] Sensory and motor neurons as well as spinal
tracts exist within the spinal cord, as axons propagate out of
the tract into the body for contact.The spinal cord consists of
the cervical spine, thoracic spine, lumbar and sacral areas.
Each can be used to classify a type of SCI, depending on
where damage occurred. [2]
Loss of muscular control and peripheral nerve damage are
the reason for incorporation of biopotential feedback. [6] Lack
of a neural systemto efficiently translate messages to
extremities for action qualifies an individual for both FES and
BCI interaction.
B. Foot drop and the Peroneal Nerve
Foot drop happens often in SCI and stroke patients, where the
patient’s foot dips downward and drags as a step is taken. This
results from weak dorsiflexors, and also weak or lack of total
mobility of the plantar flexors. Spasticity in this area as well is
common, resulting in poor control.
The use of FES with foot drop has been shown to increase
gait velocity, yet often many tests are done in an unrealistic
setting; a small distance with even ground.More challenging
surfaces are not usually incorporated into the study mainly for
the purpose of achieving basic walking by
Testing for the carry-over loss time period of
SCI patients via FES in conjunction with BCI
(May 2016)
Emily Koehler, Undergraduate Biomedical Engineering
themselves, but experiments like these have been done in
accordance with endurance and stride time variability.
The peroneal nerve is directly related to foot dorsiflexion,
and stimulates the top of the foot to lift upwards and flex.
This is the site of stimulation when applying electrodes.
Figure 1: Peroneal Nerve. [3]
C. EEG
EEG or Electroencephalogram, tracks electrical activity of the
brain. [4] Often, medical professionals will administer EEG
tests to analyze any problems associated with brain activity or
function. Brain waves can be tracked that directly are related
to different levels of thinking, motor control, memorization,
sensory controland more.
EEG is often used in conjunction with BCI to get a
biopotential feedback for control systems with SCI or
paralysis patients.BCI-FES systems that are monitored with
help of EEG feedback have proven to be helpful in restoration
of motor control, and compared to EMG feedback, and often
proves as being more reliable. [5]
D. BCI
BCI’s are often used with patients who have lost total control
of manipulating their extremities to move. Essentially, these
people are trapped within their own body, and target cells are
not reached by messenger impulses to evoke an action. [9]
BCI utilizes the patient’s nervous systems and acts as a
mediation alternative for output that has since been damaged.
“Byocybernetics”,or the use of biological feedback to
manipulate and control systems other than for just
rehabilitation purposes has large applications, but as for now
is mainly constrained in research trials. These systems take in
the usualcommands given by the nervous systemfor specific
actions,send them to the interface where they are translated
into physical controls by means of an algorithm. [10] Motor
imagery, or the portrayal of movement without such
movement through data,assists both the one administering the
EEG and the patient in the cognitive process.
E. BCI and FES
BCI analyzes all types of neural signals, including predicted
and non-predicted signals. These unpredicted signals are not
usually in synch,and therefore might suggest some level of
cognitive deficiency. As of recent study,BCI-FES systems
have been implemented mainly with upper extremities only.
For example, a group at the University at California developed
a BCI-FES systemto motivate walking in conjunction with
EEG signals, specifically foot dorsiflexion. Once the patient
became accustomed to the FES, the BCI systemwas
incorporated. Movements were made by the patient to their
best degree, then stimulation through the FES was
administered to excite the muscle groups to further activate a
walking motion. A parastep systemwas incorporated. Prior to
the actual experiment, they also were required to go through a
BCI training period. The brain control interface introduced a
virtual reality environment, where a patient would try and
manipulate movements by being in a false environment while
still immobile. Thus, EEG signals were gathered from this part
of the training and analyzed to better understand the
relationships made between these attempts at motor control.
The FES helped to accommodate specific subjects based on
time and complexity of the movements they were capable of.
Full FES training was performed to the point where the patient
would be able to walk a set distance without exterior help
from anyone.After they mastered this, the BCI was integrated.
[10] Lower extremity control, while important, usually is
secondary to motor control of the upperbody. Wheelchair
accessibility often can replace or restore mobility to patients
with lower extremity paralysis, while upper paralysis does not
have much of a common replacement. In addition, lower
extremities are believed to stimulate more noise and stimuli
compared to upperbody (walking/stepping as opposed to
grasping and flexing of arms) and thus would need more
specified EEG algorithms to cancel out this excessive data.
[10]
F. Carryover Effect
The “carryover” effect is an unusualsituation in
which a patient regains lost muscle memory post trauma (SCI
or paralysis). This phenomenon is linked to some sort of
stimulation, either deriving from the central nervous systemor
the peripheral nerves themselves that induce therapeutic
connections with past physical mobility. The hypothesis is that
FES therapy helps reconnect and retrain the neural-motor
pathways that have been damaged but previously been used
successfully.Neural plasticity, or the imprinted ability to
perform or complete a task from being done repetitively in a
previous state,in some way still exists after the damage. FES
in some cases has seemed to initiate carry-over, but it also has
been seen in cases where FES was not implemented. [10] This
proves the fact that carry over is still a sort of mystery, and
that its true cause is yet to be discovered.
Post stroke patients number one focus mainly is gait
improvement. [11] However, the carry over effect has
occurred in otherareas besides lower extremity muscles, but is
most often tested for in the lower hemisphere. Various
mechanisms have been hypothesized to induce the carry-over
effect, including central therapeutic benefits and also
peripheral mechanism benefits from patients being treated via
FES. Peripheral mechanisms, with regards to small nerve
endings of bone, skin, muscle and othertissue,are stimulated
and translate signals to our brain. These peripheral nerves
have been guessed to regenerate to some degree after stroke or
serious CNS damage. [12] With the help of FES,
improvements in peripheral mechanisms are believed to be
one area for possible reasons where carry-over can be
initiated. Ideas like strengthening remaining pathways post
trauma, improvement of flexibility and stretch degree of the
extremity, and a degradation of spastic movement in the
extremity all have been thought of to be reasons good enough
for inducing the effect. Yet, after further analysis, each proves
to have implications that would prove it to be the best reason
possible for the phenomena. Pathways that are still strong and
can be voluntary controlled most likely can be improved upon
with just simple exercise, not FES. In addition, passive
psychotherapeutic stretching would be a good enough
alternative to increasing flexibility of lost muscle mass, not as
far as going through FES therapy. Lastly, although FES can
improve spasticity,not every muscle area that has spasticity
also has the carry-over effect. It has been proven that carry
over can also occur in muscle groups that don’t inhibit spastic
movements post trauma. [13]
Central therapeutic advantages relate to the central
nervous systemultimately being improved upon as a result of
functional electrical stimulation. Once again, these are just
hypotheses.FES via surface electrodes stimulate motor and
sensory neurons,and that stimulation of the affected site can
in turn elicit cortical remapping that possibly was not done
prior to stimulation. In anothersense,high frequency sensory
stimulation might be capable of connecting and modifying
cortical connections [13]
The brain at adulthood is still capable of recovery
from damage, and forming new neural pathways,not believed
to be true until recently. [14] Cortical remapping occurs when
the CNS is destroyed or impacted by an external or internal
stimulus that as a result changes the physiology or makeup.
This reorganization can vary, and the extent still isn’t fully
understood. Post stroke reorganization usually includes the
secretion of growth factors, new copying of gene sequences,
neurotransmitter receptor modifications, new synapse and
axon creation. [15] Imaging techniques analyze these changes
and can link things like thermal activity and spatial resolution
to changes in performance. Thus,cortical remapping is very
relevant after trauma and might be a carryover cause.[13] The
ipsilateral pathway takes over and becomes a main neural
pathway to aid connections post stroke.[10] Ipsilateral,
meaning same side, has precedence when a specific extremity
is in rehabilitation. Therefore, it is this pathway that is often
looked at and studied when doing carry-over experimental
trials.
Other hypothesesalso exist, more of the
proprioceptive kind, a mix of central and peripheral
stimulation as mentioned earlier. FES coupled with predictive
and confident movement of the lost site as a closed loop
systemnative to a patient’s own sensory motor organization
has been hypothesized to initiate an ability to correct damage
from trauma. [10] Basically, the FES helps to stimulate the
area, but the patient is aware and understands howthe
movement needs to be carried out and what it feels like once it
is done. These two aspects combined are thought to have a
dual effect on carry over coming into play. This dual effect
thus triggers muscle memory, or “neural plasticity” and the
regaining of the lost movement occurs. [16]
Other not as prevalent hypotheses forcarry-over
include antidromic firing and its relationship to Hebb
synapses.Antidromic firing, occurring from the opposite
impulse travelling down the axon after hitting the anterior
horn cell after a motor nerve fiber is activated, can occur when
patterns of quick electrical impulses are administered to a site.
This can showup on an EMG as a smaller but present wave.
[16] This discharge before or almost at the same time as
presynapse are called Hebb synapses.These are related to the
Hebbian theory,or the adjustment of neurons in the brain
when exposed to being in a learning or memory state.The
presynaptic cell ultimately affects and strengthens the post
synaptic.Basically, a common saying being that “cells that
fire together,wire together.” [17] Thus,a cell X usually will
fire before a cell Y, and even might strengthen the firing of Y.
The almost simultaneous firing of X and Y strengthens the
learning process and unity of the cells to perform a task. [16]
This all leads to a network of uniform muscle memory and
rehabilitation learning, which could provide carry-over clues.
Carryover in this experiment will be assessed by an
automatic comprehensive method-logarithm based on
minimum variables detected away from normalcy, discovered
by a research team testing for functional improvement
assessment oftherapeutic experiments with FES. This process
tests for specific parameters when using FES in patients
specific to foot drop, that will contribute to a patient possibly
acquiring the carryover effect sometime during the therapy.
After data acquisition is finished, information will be inserted
into a software that computes a raw score. This raw score,
called a capacity score, is tested for before experimental trial,
during, and after, to compute progress and improvement time
segments.Thus, this raw score is presented as a yes or no
statement if carry over has occurred or not. [18]
III. PREVIOUS EXPERIMENTS ON CARRY OVER
For most experiments, carryover is observed at the end of an
experiment, or hypothesized to have happened during. One
foot drop experimental systemused the NESS L300 to use
active therapy FES to correct foot drop in a closed loop cycle
so the patient could have a systemthe adjust stimulation in
relation to their relative output.Like the parameters of the
carryover algorithm, status offoot drop progression was
analyzed prior, during therapy, and almost a year after to
detect stimulation results and to detect carryover. No modality
to categorize the detection of carryover was stated.
In a different study, foot drop as a result of stroke was
tested against FES and AFO, ankle-foot orthotics.Stated in
this experiment, the peroneal nerve was stimulated during the
swing phase of gait through a dual channel FES system. The
thought was that the coupled repetitive stimulation to the
peroneal nerve with the increased amount of stimulation
feedback to the central nervous systemwould elicit
carryover. They found that after FES was turned off, not
increase in walking speed on one’s own was present,but
during a static voluntary test some form of voluntary control
progress was shown that lead them to believe in a small
presence of carryover.
The last case presented was focused on and continued over
a duration of 9 months. Patients were assessed for
improvement two months and then a year later with both FES
and non-FES therapy. 31% of available patients were found to
not need any assistance and could completely walk on their
own at the one-year period. Carryover was based on a baseline
between beginning of therapy and a year later both with
neuroprosthesis.A clear definition of how exactly carryover
was assessed and analyzed was not presented. They suggest a
plateau effect for FES use at which the subject can fully
perform on their own past the use of the stimulation, as gait
velocity increased past the therapy. Usually gait velocity is
either thought to stay constant orrecess without stimulation
help, but with the recordings after a year without
neuroprsthesis still being higher than at the end of the study,
carryover was thought to have been the reasoning.
IV. EXPERIMENTAL SECTION
A. Materialsand Methods
A group of 30 people will be recruited for this experiment, 15
men and 15 women, all first time SCI patients. Patients will be
recruited based on similar injury location sites,to keep
variables as constant as possible. 3 groups of 5 will be tested
at once (1 15 person FES group and 1 without.) The first
group will be exposed to FES for 6 months, the next 9, and
then the last 1 year.
Exclusion criteria: degree of ankle flex being less than 5
degrees,language or cognitive defects, inability to walk even
if assisted,spasticity at ankle, skin or open wounds at
electrode sites, medical issues that may interfere with
experiment (neurological or muscular), damaged peroneal
nerve, not available for test time period, subjects under18.[25]
Inclusion Criteria: determination of clear spinal cord injury
and classification, clear foot drop during gait swing, 6 months
at least after injury, informed consent is not an issue.
Hemiplegic patients only, as a result of spinal hemiplegia.
Note that the situation involving how the patient was affected
is not relevant in this study.[25]
Control group: Same age and gender average for each
impaired patient, same relative average walking speed and
foot drop severity. Keeping our subjects as even as possible
will result for the best most unbiased results,so all will be
analyzed prior to acceptance into the test with relative
uniformity of foot drop severity. The control group will have
no FES but all of the same therapy techniques and duration
times. They will serve as a basis and utilize the same test and
carryover assessment at the end. The goal is to find a clear
distinction in carryover present in subjects in one of the three
therapy groups that may lean towards a threshold time for
carryover to be initiated in conjunction with FES.
Subjects will first be assessed on personalparameters. Each
group will have a subsequent controlgroup,with a total of 6
groups each of 5 people. The first group will go through
therapy for a period of 6 months, the second 9, and the third a
full year. Each will be assessed forcapacity score parameters
prior to the experiment, halfway through their trial, and then 6
months following.
B. Signal Acquisition
The EEG cap will consist of 64 electrodes, and 2 electrodes
will be placed on the peroneal nerve (high calf, low calf.)
Impedance values will be kept at 3 k. Current stimulation
will be in the range of 80-100 mA.
Being that this experiment is hypothetical,actual electrical
stimulation parameters are vague because of varying factors.
Tissue potential damage, surface electrode size, and
degradation of the electrode must come to mind, especially in
the 1-year group. Waveform would be rectangular, and
biphasic to allow for least amount of uncomfortable sensation
to patient. Being that we are specifically activating the
peroneal nerve, short pulses of less than 200 s will be used.
Impedance thus should be low and current evenly spread. [20]
C. Prior Testing for Impairment
Prior to the experiment to begin, each subject will be
analyzed based on gait velocity, endurance velocity, paretic
step length, and obvious clear fluidity in
movements/spasticity.To ensure patients have needed
inclusion criteria based on SCI similarities, a MRC scale index
via ankle dorsiflexion will be used. Grade 3 is wanted index;
medium resistance to force and muscle control. Muscle
strength is further reduced such that the joint can be moved
only against gravity with the examiner's resistance completely
removed, based on effort scale of patient. [21]
In addition, every patient will go through a calibration
process with the EEG to allow those administering the test to
see clear differences between foot dorsiflexion and relaxation,
as well as gait movement. This way understanding ofvarious
EEG signals will be assumed during testing.
These parameters will be incorporated into the
comprehensive assessment discussed earlier in carryover to
test for capacity score. The following is a proposed
experiment to test for threshold time to in regards to carryover
in footdrop patients via FES with a EEG-BCI system.
D. Experimental Set Up
BCI will allow patients to control FES on their own and
ideally speed up the neural plasticity aspect of this experiment.
The FES system used will stimulate the peroneal nerve via
surface electrodes of the respective leg with foot drop. An
EEG cap and BCI computer will allow for a feedback system
while the patient performs dorsiflexion. Note that the physical
system will be mobile, and performed on a lateral treadmill
with wires all out of the way for movements of the leg. EEG
information will be interpreted by a BCI computer, which
sends information to a MCU (microcontroller unit) that then
sends feedback to the FES to aid dorsiflexion. A bio amplifier
unit is also present to analyze the EEG signals originating
from the cap. See figure 2. Being that the computer will be
controlling the FES, amplitude and stimulation will need to be
addressed to allow the computer to operate at an optimal level.
In addition, adding a a switch function during wanted and
unwanted times of FES application will also be utilized as
done in previous experiments. [22]
Figure 2: System setup; EEG-BCI interface with electrodes for foot
dorsiflexion. Experimental set up based on similar setup shown. [22]
Therapy testing will include walking over a 15ft distance,
static ankle dorsiflexion, and analyzation of gait velocity.
Subjects will meet 4 times a week for 45 minute sessions that
will increase based on patient ease and comfort. All data will
be kept in excel spreadsheets. If this amount of time poses to
be too much at first for the patient, it will be altered being that
we are looking for a larger time of FES correlation. The group
will be considered as a whole in relation to carry over present
or not; if majority experienced carryover then correlation will
be counted positive.
V. RESULTS AND DISCUSSION
Figure 4: Mock table for results. The more "Yes" responses to the
carryover column after capacity score analyzation means there might
be a clue to this group containing threshold time.
A. Proposed Results
From past experiments, the control group most likely will
not benefit as highly from therapy as the FES group did.
Assuming this is true will give a positive foundation for our
carryover assumptions to focus on.
Ideally, a linear relationship between subject improvement
based on the capacity score and therapy time is what we would
want to see. A linear improvement however past 1 year would
tell us that maybe we haven’t reached a threshold yet that
would suggest a FES time period to induce carryover.
Capacity scores will be analyzed and give an output of
patient’s results. Simple yes or no’s will state for carryover.
However, more positive capacity scores during the middle
time therapies may suggest ourthreshold is around 6-9
months. This is difficult with 5 subjects pergroup, and as
analyzed in other experiments usually subject number drops
because of subject availability or factors that can’t be
controlled.
Figure 3:
Foot dorsiflexion on one's own versus BCI-FES control. Example of
EEG data seen in system. [22]
Data like Figure 3 will be used to analyze effort and how the
BCI-EEG interaction is working, and is a good example of
how data should look after needed calibration and
understanding ofsystemsetup. [23]
In addition, analyzation of EEG waves will be important if a
correlation is found; brainwaves of the central nervous system
might hint at cortical remapping of neural pathways needed to
correct foot drop.
Increase in gait velocity at the post-rehabilitation checkup
from when the experiment was taking place, fluidity of
movement, larger angle dorsiflexion and no or little spasticity
are ideal outcomes of this experiment,
It is possible that there is no carryover time correlation to
FES, and results are inconclusive.
B. Discussion and Conclusion
Being that this is a hypotheticalexperiment, many of these
parameters would have to be ensured that they won’t play a
big role in altering our variables. A majority of the specifics
have already been incorporated into FES study, such as
successfully BCI-FES integration, foot drop analyzation, but
not threshold carryover time. Major areas of concern regarding
this experiment’s success revolve around the therapy time.
Patients can not all have the same level and type of SCI injury,
which provides a basis for error. In addition, motivation of
each patient will vary in regards to their training. While one
patient might be very dedicated to the process,anotherin the
same or different group might not.
In addition, as we know with EEG slight movements like
eye blinks, coughing,swallowing, etc. will showup on an
EEG pattern. By having our subjects walk and move as they
would normally, we introduce lots of motion artifacts and
excess noise that would have to be calibrated out to really see
differences in EEG that stand for foot dorsiflexion.
Realistically, we might even be able to simplify the system
and just stick to an FES systemversus threshold time and have
stimulation monitored by therapists.
In addition, an apparatus to ensure a moving treadmill with
all required features of the systemon a moving systemas well
is needed so that mobility of the subject is not restricted to
mobility of the unit.
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2011.
[23]"The Neural Correlates of Long-Term Carryover
following Functional Electrical Stimulation for Stroke : Table
1", Hindawi.com, 2016. [Online]. Available:
http://www.hindawi.com/journals/np/2016/4192718/tab1/.
[Accessed:06- May- 2016].
[24]T. Watanabe,S. Endo, K. Murakami, Y. Kumagai and N.
Kuge, "A Measurement of Lower Limb Angles Using
Wireless Inertial Sensors during FES Assisted Foot Drop
Correction with and without Voluntary Effort", IJBBB, pp.
216-220, 2013.
[25]Y. Laufer, H. Ring, E. Sprecher and J. Hausdorff, "Gait in
Individuals with Chronic Hemiparesis: One-Year Follow-up
of the Effects of a Neuroprosthesis That Ameliorates Foot
Drop", Journal of Neurologic Physical Therapy, vol. 33, no. 2,
pp. 104-110, 2009.
[26]R. Martin, C. Sadowsky, K. Obst, B. Meyer and J.
McDonald, "Functional Electrical Stimulation in Spinal Cord
Injury: From Theory to Practice", Topicsin Spinal Cord Injury
Rehabilitation,vol. 18, no. 1, pp. 28-33, 2012.
[27]"Hemiplegia: Definition, diagnosis and phases",2016.
[Online]. Available:
https://www.nscisc.uab.edu/Public/Facts%202015.pdf.
[Accessed:06- May- 2016].
[28]M. KAFRI AND Y. LAUFER, "THERAPEUTIC EFFECTSOF
FUNCTIONAL ELECTRICALSTIMULATIONON GAIT IN
INDIVIDUALSPOST-STROKE",ANNALS OF BIOMEDICAL
ENGINEERING,VOL.43, NO.2, PP.451-466, 2014

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Testing for the carry-over loss time period of SCI patients via FES in conjunction with BCI (May 2016)

  • 1.  Abstract—Functional electricalstimulationis a therapy based procedure where muscles are activated via electrical signals to target stimulation of lost connection between the CNS andmotor neurons. During FES application, patients are retaught basic movements and functions through the use of ergometers or simple therapy instructions. Loss of muscularcontrol and peripheral nerve damage are the basic reasons for needof biopotential feedback . Often, in patients with SCI, use of EEG is an effective way to track electrical activity in the brain whilst movements are done. Lack of a neural system to efficiently translate messages to extremities foraction can qualify an individual for both FES and BCI interaction. Thus, EEG is often usedin conjunction with BCI to get a biopotential feedback for control systems with SCIor paralysis patients. BCI-FES systems that are monitored with helpof EEG feedback have proven to be helpful in restoration of motor control, and compared to EMG feedback, and often proves as being more reliable. [2] However, in many FES studies, a phenomenon known as the carryover effect has been recorded to take place. This effect is when patients regain the ability to complete motor tasks after stroke or SCI, thought to be triggeredfrom FES and rehabilitation of muscle memory. However, the period of time where carryover is present and initiates is unknown. This experiment is designedto see if there is a correlation between FES therapy time and duration of carry-over persisting or occurring in a patient. Foot drop patients were grouped into 3 sub groups all with varying time periods of applied therapy, ranging from 6 months to 1 year. The FES system was made up of an EEG-BCI interface connectedto a feedback loop to allow stimulation of the peroneal nerve. A capacity score based algorithm on how much improvement within a time frame occurred as a result of carryover was usedto detect the phenomenon. I. INTRODUCTION Functional electrical stimulation aids to help patients recover movement of lost extremity control from stroke or SCI, especially when administered over a long time period with frequent therapy sessions.Both duration of stimulation and type are large factors in the determination of neural plasticity producing the carryover effect in a patient. 5/4/16. This work was supported by the UB Biomedical Engineering Department. Emily Koehler, Biomedical Engineering undergraduate, University at Buffalo. emilykoe@buffalo.edu However, the carryover effect has no true trigger, therefore its classification of occurring can vary. We are still unsure of when FES ends and voluntary control takes over. If this range of time was found,then therapeutic stimulation to those with SCI and stroke could be narrowed down to a specific range to allow patients to potentially see and be somewhat guaranteed (based on therapy sessions)some sort of control of lost muscle mass again. These time frames can be tested and applied on different types oftrauma to broaden our understanding of cortical remapping. FES systems and clinical therapy would be able to modify current procedures in rehabilitation to allow for a window of maximal time where carryover can be initiated. II. BACKGROUND A. Spinal Cord Injury The spinal cord is the site of motor and sensory stimulation passing through the central nervous systemand the rest of the human body. According to the NSCSC, there are near 12,500 new SCI injuries per year in the United States,with an average age of 42. [1] Sensory and motor neurons as well as spinal tracts exist within the spinal cord, as axons propagate out of the tract into the body for contact.The spinal cord consists of the cervical spine, thoracic spine, lumbar and sacral areas. Each can be used to classify a type of SCI, depending on where damage occurred. [2] Loss of muscular control and peripheral nerve damage are the reason for incorporation of biopotential feedback. [6] Lack of a neural systemto efficiently translate messages to extremities for action qualifies an individual for both FES and BCI interaction. B. Foot drop and the Peroneal Nerve Foot drop happens often in SCI and stroke patients, where the patient’s foot dips downward and drags as a step is taken. This results from weak dorsiflexors, and also weak or lack of total mobility of the plantar flexors. Spasticity in this area as well is common, resulting in poor control. The use of FES with foot drop has been shown to increase gait velocity, yet often many tests are done in an unrealistic setting; a small distance with even ground.More challenging surfaces are not usually incorporated into the study mainly for the purpose of achieving basic walking by Testing for the carry-over loss time period of SCI patients via FES in conjunction with BCI (May 2016) Emily Koehler, Undergraduate Biomedical Engineering
  • 2. themselves, but experiments like these have been done in accordance with endurance and stride time variability. The peroneal nerve is directly related to foot dorsiflexion, and stimulates the top of the foot to lift upwards and flex. This is the site of stimulation when applying electrodes. Figure 1: Peroneal Nerve. [3] C. EEG EEG or Electroencephalogram, tracks electrical activity of the brain. [4] Often, medical professionals will administer EEG tests to analyze any problems associated with brain activity or function. Brain waves can be tracked that directly are related to different levels of thinking, motor control, memorization, sensory controland more. EEG is often used in conjunction with BCI to get a biopotential feedback for control systems with SCI or paralysis patients.BCI-FES systems that are monitored with help of EEG feedback have proven to be helpful in restoration of motor control, and compared to EMG feedback, and often proves as being more reliable. [5] D. BCI BCI’s are often used with patients who have lost total control of manipulating their extremities to move. Essentially, these people are trapped within their own body, and target cells are not reached by messenger impulses to evoke an action. [9] BCI utilizes the patient’s nervous systems and acts as a mediation alternative for output that has since been damaged. “Byocybernetics”,or the use of biological feedback to manipulate and control systems other than for just rehabilitation purposes has large applications, but as for now is mainly constrained in research trials. These systems take in the usualcommands given by the nervous systemfor specific actions,send them to the interface where they are translated into physical controls by means of an algorithm. [10] Motor imagery, or the portrayal of movement without such movement through data,assists both the one administering the EEG and the patient in the cognitive process. E. BCI and FES BCI analyzes all types of neural signals, including predicted and non-predicted signals. These unpredicted signals are not usually in synch,and therefore might suggest some level of cognitive deficiency. As of recent study,BCI-FES systems have been implemented mainly with upper extremities only. For example, a group at the University at California developed a BCI-FES systemto motivate walking in conjunction with EEG signals, specifically foot dorsiflexion. Once the patient became accustomed to the FES, the BCI systemwas incorporated. Movements were made by the patient to their best degree, then stimulation through the FES was administered to excite the muscle groups to further activate a walking motion. A parastep systemwas incorporated. Prior to the actual experiment, they also were required to go through a BCI training period. The brain control interface introduced a virtual reality environment, where a patient would try and manipulate movements by being in a false environment while still immobile. Thus, EEG signals were gathered from this part of the training and analyzed to better understand the relationships made between these attempts at motor control. The FES helped to accommodate specific subjects based on time and complexity of the movements they were capable of. Full FES training was performed to the point where the patient would be able to walk a set distance without exterior help from anyone.After they mastered this, the BCI was integrated. [10] Lower extremity control, while important, usually is secondary to motor control of the upperbody. Wheelchair accessibility often can replace or restore mobility to patients with lower extremity paralysis, while upper paralysis does not have much of a common replacement. In addition, lower extremities are believed to stimulate more noise and stimuli compared to upperbody (walking/stepping as opposed to grasping and flexing of arms) and thus would need more specified EEG algorithms to cancel out this excessive data. [10] F. Carryover Effect The “carryover” effect is an unusualsituation in which a patient regains lost muscle memory post trauma (SCI or paralysis). This phenomenon is linked to some sort of stimulation, either deriving from the central nervous systemor the peripheral nerves themselves that induce therapeutic connections with past physical mobility. The hypothesis is that FES therapy helps reconnect and retrain the neural-motor pathways that have been damaged but previously been used successfully.Neural plasticity, or the imprinted ability to perform or complete a task from being done repetitively in a previous state,in some way still exists after the damage. FES in some cases has seemed to initiate carry-over, but it also has been seen in cases where FES was not implemented. [10] This proves the fact that carry over is still a sort of mystery, and that its true cause is yet to be discovered. Post stroke patients number one focus mainly is gait improvement. [11] However, the carry over effect has occurred in otherareas besides lower extremity muscles, but is most often tested for in the lower hemisphere. Various mechanisms have been hypothesized to induce the carry-over effect, including central therapeutic benefits and also
  • 3. peripheral mechanism benefits from patients being treated via FES. Peripheral mechanisms, with regards to small nerve endings of bone, skin, muscle and othertissue,are stimulated and translate signals to our brain. These peripheral nerves have been guessed to regenerate to some degree after stroke or serious CNS damage. [12] With the help of FES, improvements in peripheral mechanisms are believed to be one area for possible reasons where carry-over can be initiated. Ideas like strengthening remaining pathways post trauma, improvement of flexibility and stretch degree of the extremity, and a degradation of spastic movement in the extremity all have been thought of to be reasons good enough for inducing the effect. Yet, after further analysis, each proves to have implications that would prove it to be the best reason possible for the phenomena. Pathways that are still strong and can be voluntary controlled most likely can be improved upon with just simple exercise, not FES. In addition, passive psychotherapeutic stretching would be a good enough alternative to increasing flexibility of lost muscle mass, not as far as going through FES therapy. Lastly, although FES can improve spasticity,not every muscle area that has spasticity also has the carry-over effect. It has been proven that carry over can also occur in muscle groups that don’t inhibit spastic movements post trauma. [13] Central therapeutic advantages relate to the central nervous systemultimately being improved upon as a result of functional electrical stimulation. Once again, these are just hypotheses.FES via surface electrodes stimulate motor and sensory neurons,and that stimulation of the affected site can in turn elicit cortical remapping that possibly was not done prior to stimulation. In anothersense,high frequency sensory stimulation might be capable of connecting and modifying cortical connections [13] The brain at adulthood is still capable of recovery from damage, and forming new neural pathways,not believed to be true until recently. [14] Cortical remapping occurs when the CNS is destroyed or impacted by an external or internal stimulus that as a result changes the physiology or makeup. This reorganization can vary, and the extent still isn’t fully understood. Post stroke reorganization usually includes the secretion of growth factors, new copying of gene sequences, neurotransmitter receptor modifications, new synapse and axon creation. [15] Imaging techniques analyze these changes and can link things like thermal activity and spatial resolution to changes in performance. Thus,cortical remapping is very relevant after trauma and might be a carryover cause.[13] The ipsilateral pathway takes over and becomes a main neural pathway to aid connections post stroke.[10] Ipsilateral, meaning same side, has precedence when a specific extremity is in rehabilitation. Therefore, it is this pathway that is often looked at and studied when doing carry-over experimental trials. Other hypothesesalso exist, more of the proprioceptive kind, a mix of central and peripheral stimulation as mentioned earlier. FES coupled with predictive and confident movement of the lost site as a closed loop systemnative to a patient’s own sensory motor organization has been hypothesized to initiate an ability to correct damage from trauma. [10] Basically, the FES helps to stimulate the area, but the patient is aware and understands howthe movement needs to be carried out and what it feels like once it is done. These two aspects combined are thought to have a dual effect on carry over coming into play. This dual effect thus triggers muscle memory, or “neural plasticity” and the regaining of the lost movement occurs. [16] Other not as prevalent hypotheses forcarry-over include antidromic firing and its relationship to Hebb synapses.Antidromic firing, occurring from the opposite impulse travelling down the axon after hitting the anterior horn cell after a motor nerve fiber is activated, can occur when patterns of quick electrical impulses are administered to a site. This can showup on an EMG as a smaller but present wave. [16] This discharge before or almost at the same time as presynapse are called Hebb synapses.These are related to the Hebbian theory,or the adjustment of neurons in the brain when exposed to being in a learning or memory state.The presynaptic cell ultimately affects and strengthens the post synaptic.Basically, a common saying being that “cells that fire together,wire together.” [17] Thus,a cell X usually will fire before a cell Y, and even might strengthen the firing of Y. The almost simultaneous firing of X and Y strengthens the learning process and unity of the cells to perform a task. [16] This all leads to a network of uniform muscle memory and rehabilitation learning, which could provide carry-over clues. Carryover in this experiment will be assessed by an automatic comprehensive method-logarithm based on minimum variables detected away from normalcy, discovered by a research team testing for functional improvement assessment oftherapeutic experiments with FES. This process tests for specific parameters when using FES in patients specific to foot drop, that will contribute to a patient possibly acquiring the carryover effect sometime during the therapy. After data acquisition is finished, information will be inserted into a software that computes a raw score. This raw score, called a capacity score, is tested for before experimental trial, during, and after, to compute progress and improvement time segments.Thus, this raw score is presented as a yes or no statement if carry over has occurred or not. [18] III. PREVIOUS EXPERIMENTS ON CARRY OVER For most experiments, carryover is observed at the end of an experiment, or hypothesized to have happened during. One foot drop experimental systemused the NESS L300 to use active therapy FES to correct foot drop in a closed loop cycle so the patient could have a systemthe adjust stimulation in relation to their relative output.Like the parameters of the carryover algorithm, status offoot drop progression was analyzed prior, during therapy, and almost a year after to detect stimulation results and to detect carryover. No modality to categorize the detection of carryover was stated. In a different study, foot drop as a result of stroke was tested against FES and AFO, ankle-foot orthotics.Stated in this experiment, the peroneal nerve was stimulated during the swing phase of gait through a dual channel FES system. The thought was that the coupled repetitive stimulation to the peroneal nerve with the increased amount of stimulation feedback to the central nervous systemwould elicit
  • 4. carryover. They found that after FES was turned off, not increase in walking speed on one’s own was present,but during a static voluntary test some form of voluntary control progress was shown that lead them to believe in a small presence of carryover. The last case presented was focused on and continued over a duration of 9 months. Patients were assessed for improvement two months and then a year later with both FES and non-FES therapy. 31% of available patients were found to not need any assistance and could completely walk on their own at the one-year period. Carryover was based on a baseline between beginning of therapy and a year later both with neuroprosthesis.A clear definition of how exactly carryover was assessed and analyzed was not presented. They suggest a plateau effect for FES use at which the subject can fully perform on their own past the use of the stimulation, as gait velocity increased past the therapy. Usually gait velocity is either thought to stay constant orrecess without stimulation help, but with the recordings after a year without neuroprsthesis still being higher than at the end of the study, carryover was thought to have been the reasoning. IV. EXPERIMENTAL SECTION A. Materialsand Methods A group of 30 people will be recruited for this experiment, 15 men and 15 women, all first time SCI patients. Patients will be recruited based on similar injury location sites,to keep variables as constant as possible. 3 groups of 5 will be tested at once (1 15 person FES group and 1 without.) The first group will be exposed to FES for 6 months, the next 9, and then the last 1 year. Exclusion criteria: degree of ankle flex being less than 5 degrees,language or cognitive defects, inability to walk even if assisted,spasticity at ankle, skin or open wounds at electrode sites, medical issues that may interfere with experiment (neurological or muscular), damaged peroneal nerve, not available for test time period, subjects under18.[25] Inclusion Criteria: determination of clear spinal cord injury and classification, clear foot drop during gait swing, 6 months at least after injury, informed consent is not an issue. Hemiplegic patients only, as a result of spinal hemiplegia. Note that the situation involving how the patient was affected is not relevant in this study.[25] Control group: Same age and gender average for each impaired patient, same relative average walking speed and foot drop severity. Keeping our subjects as even as possible will result for the best most unbiased results,so all will be analyzed prior to acceptance into the test with relative uniformity of foot drop severity. The control group will have no FES but all of the same therapy techniques and duration times. They will serve as a basis and utilize the same test and carryover assessment at the end. The goal is to find a clear distinction in carryover present in subjects in one of the three therapy groups that may lean towards a threshold time for carryover to be initiated in conjunction with FES. Subjects will first be assessed on personalparameters. Each group will have a subsequent controlgroup,with a total of 6 groups each of 5 people. The first group will go through therapy for a period of 6 months, the second 9, and the third a full year. Each will be assessed forcapacity score parameters prior to the experiment, halfway through their trial, and then 6 months following. B. Signal Acquisition The EEG cap will consist of 64 electrodes, and 2 electrodes will be placed on the peroneal nerve (high calf, low calf.) Impedance values will be kept at 3 k. Current stimulation will be in the range of 80-100 mA. Being that this experiment is hypothetical,actual electrical stimulation parameters are vague because of varying factors. Tissue potential damage, surface electrode size, and degradation of the electrode must come to mind, especially in the 1-year group. Waveform would be rectangular, and biphasic to allow for least amount of uncomfortable sensation to patient. Being that we are specifically activating the peroneal nerve, short pulses of less than 200 s will be used. Impedance thus should be low and current evenly spread. [20] C. Prior Testing for Impairment Prior to the experiment to begin, each subject will be analyzed based on gait velocity, endurance velocity, paretic step length, and obvious clear fluidity in movements/spasticity.To ensure patients have needed inclusion criteria based on SCI similarities, a MRC scale index via ankle dorsiflexion will be used. Grade 3 is wanted index; medium resistance to force and muscle control. Muscle strength is further reduced such that the joint can be moved only against gravity with the examiner's resistance completely removed, based on effort scale of patient. [21] In addition, every patient will go through a calibration process with the EEG to allow those administering the test to see clear differences between foot dorsiflexion and relaxation, as well as gait movement. This way understanding ofvarious EEG signals will be assumed during testing. These parameters will be incorporated into the comprehensive assessment discussed earlier in carryover to test for capacity score. The following is a proposed experiment to test for threshold time to in regards to carryover in footdrop patients via FES with a EEG-BCI system. D. Experimental Set Up BCI will allow patients to control FES on their own and ideally speed up the neural plasticity aspect of this experiment. The FES system used will stimulate the peroneal nerve via surface electrodes of the respective leg with foot drop. An EEG cap and BCI computer will allow for a feedback system while the patient performs dorsiflexion. Note that the physical system will be mobile, and performed on a lateral treadmill with wires all out of the way for movements of the leg. EEG information will be interpreted by a BCI computer, which sends information to a MCU (microcontroller unit) that then sends feedback to the FES to aid dorsiflexion. A bio amplifier unit is also present to analyze the EEG signals originating from the cap. See figure 2. Being that the computer will be controlling the FES, amplitude and stimulation will need to be
  • 5. addressed to allow the computer to operate at an optimal level. In addition, adding a a switch function during wanted and unwanted times of FES application will also be utilized as done in previous experiments. [22] Figure 2: System setup; EEG-BCI interface with electrodes for foot dorsiflexion. Experimental set up based on similar setup shown. [22] Therapy testing will include walking over a 15ft distance, static ankle dorsiflexion, and analyzation of gait velocity. Subjects will meet 4 times a week for 45 minute sessions that will increase based on patient ease and comfort. All data will be kept in excel spreadsheets. If this amount of time poses to be too much at first for the patient, it will be altered being that we are looking for a larger time of FES correlation. The group will be considered as a whole in relation to carry over present or not; if majority experienced carryover then correlation will be counted positive. V. RESULTS AND DISCUSSION Figure 4: Mock table for results. The more "Yes" responses to the carryover column after capacity score analyzation means there might be a clue to this group containing threshold time. A. Proposed Results From past experiments, the control group most likely will not benefit as highly from therapy as the FES group did. Assuming this is true will give a positive foundation for our carryover assumptions to focus on. Ideally, a linear relationship between subject improvement based on the capacity score and therapy time is what we would want to see. A linear improvement however past 1 year would tell us that maybe we haven’t reached a threshold yet that would suggest a FES time period to induce carryover. Capacity scores will be analyzed and give an output of patient’s results. Simple yes or no’s will state for carryover. However, more positive capacity scores during the middle time therapies may suggest ourthreshold is around 6-9 months. This is difficult with 5 subjects pergroup, and as analyzed in other experiments usually subject number drops because of subject availability or factors that can’t be controlled. Figure 3: Foot dorsiflexion on one's own versus BCI-FES control. Example of EEG data seen in system. [22]
  • 6. Data like Figure 3 will be used to analyze effort and how the BCI-EEG interaction is working, and is a good example of how data should look after needed calibration and understanding ofsystemsetup. [23] In addition, analyzation of EEG waves will be important if a correlation is found; brainwaves of the central nervous system might hint at cortical remapping of neural pathways needed to correct foot drop. Increase in gait velocity at the post-rehabilitation checkup from when the experiment was taking place, fluidity of movement, larger angle dorsiflexion and no or little spasticity are ideal outcomes of this experiment, It is possible that there is no carryover time correlation to FES, and results are inconclusive. B. Discussion and Conclusion Being that this is a hypotheticalexperiment, many of these parameters would have to be ensured that they won’t play a big role in altering our variables. A majority of the specifics have already been incorporated into FES study, such as successfully BCI-FES integration, foot drop analyzation, but not threshold carryover time. Major areas of concern regarding this experiment’s success revolve around the therapy time. Patients can not all have the same level and type of SCI injury, which provides a basis for error. In addition, motivation of each patient will vary in regards to their training. While one patient might be very dedicated to the process,anotherin the same or different group might not. In addition, as we know with EEG slight movements like eye blinks, coughing,swallowing, etc. will showup on an EEG pattern. By having our subjects walk and move as they would normally, we introduce lots of motion artifacts and excess noise that would have to be calibrated out to really see differences in EEG that stand for foot dorsiflexion. Realistically, we might even be able to simplify the system and just stick to an FES systemversus threshold time and have stimulation monitored by therapists. In addition, an apparatus to ensure a moving treadmill with all required features of the systemon a moving systemas well is needed so that mobility of the subject is not restricted to mobility of the unit. REFERENCES AND FOOTNOTES A. References [1]H. Ma, "Spideroak, WhisperSystems, Silent Circle", Technical ServicesQuarterly, vol. 32, no. 2, pp. 228-229, 2015. [2]2016. [Online]. Available: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3232636/. [Accessed:06- May- 2016]. [3]"Diseases & Conditions - Medscape Reference", Emedicine.medscape.com, 2016. [Online]. Available: http://emedicine.medscape.com. [Accessed:06- May- 2016]. [4]"Electroencephalogram (EEG) | Johns Hopkins Medicine Health Library", Hopkinsmedicine.org,2016. [Online]. 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