Neurostimulation:
An Overview
Thursday Feb 28th
Shaun Comfort, MD, MBA
Adaptix Clinical Solutions, LLC
American Society for Experimental NeuroTherapeutics | 15th Annual Meeting
Disclosure(s)
Consulting relationships with
multiple Pharma, Bio, and
Medical Device Companies
Equity: J&J
American Society for Experimental NeuroTherapeutics | 15th Annual Meeting
Other:
I will discuss some currently
unapproved Rx/Research
technologies
Learning Objectives
• Outline the context & history of Neurostimulation
• Identify several current Neurostim therapies
The Brave New World of
Neurostimulation
American Society for Experimental NeuroTherapeutics | 15th Annual Meeting
Basic Definitions
• Fundamental Quantity: Charge = Coulomb
• Negative Charges: Electrons = 1.6 x 10-19 C
• Moving Charges: Current = Amp {C/sec}
• Charge Source (eg Battery): Voltage = Potential
Energy/Ch = Volt {Joules/C}
• Useful Relation: Ohm’s Law V = iR
• Other Useful Terms:
• Frequency = Cycles/sec {Hertz}
American Society for Experimental NeuroTherapeutics | 15th Annual Meeting
Basic Definitions, cont
American Society for Experimental NeuroTherapeutics | 15th Annual Meeting
Neurostimulation?
• Neurostimulation?
• The modulation of nervous system activity by
electrically activating individual or groups of
neurons in the body, to achieve a clinical goal.
• Can be achieved using:
• Surface electrodes
• Implantable electrodes
• Indirect: Vector Force Fields (TMS)
American Society for Experimental NeuroTherapeutics | 15th Annual Meeting
Early Neurostimulation?
• First application of neurostimulation:
• Scribonius Largus, 65 AD
• Torpedo fish (electric ray)
• for relieving pain (Early TENS?)
• Empirical findings that electricity applied
to skin had interesting effects such as pain
reduction
American Society for Experimental NeuroTherapeutics | 15th Annual Meeting
Coincidental Physics
American Society for Experimental NeuroTherapeutics | 15th Annual Meeting
American Society for Experimental NeuroTherapeutics | 15th Annual Meeting
Faradization for Pain Relief
American Society for Experimental NeuroTherapeutics | 15th Annual Meeting
The Good Old Days?
• Early Faradization primitive and
overly broad claims:
• “Electreat” device – Willie Kent 1st
person prosecuted under FD&C (1938)
for Unsubstantiated Claims
• Claims later limited to pain
• However, this approach evolved
into Transcutaneous Electrical
Stimulation (TENS) used today for
pain (eg, Shealy MD & Medtronics,
1970s)
American Society for Experimental NeuroTherapeutics | 15th Annual Meeting
Beyond Peripheral Faradization
• Early 20th century - co-incident advances in
electronics and medicine produced new tools for
electrophysiology: ECG (1911), EEG (Berger, 1924) and
therapy: ECT (Cerletti & Bini, 1938)
American Society for Experimental NeuroTherapeutics | 15th Annual Meeting
If That Is the Past, Where Are
We Today?
• We are riding the 20th Century wave of
Neuroscience + Moore’s Law
• The results are:
• Implantable micro-electronics
• Open (VNS, DBS) - and Closed-loop (?) therapies
• Wireless monitoring (eg, Implanted EEG)
• Smart diagnostics (eg, ECG/EEG Interpretation)
• Rapid advances in Neurosurgery, fMRI, etc
American Society for Experimental NeuroTherapeutics | 15th Annual Meeting
Moore’s Law
To 1st approximation, doubling of transistor density &
computing efficiency every 18 months
American Society for Experimental NeuroTherapeutics | 15th Annual Meeting
SCS, TENS, tDCS, etc
American Society for Experimental NeuroTherapeutics | 15th Annual Meeting
TENS, TMS, DBS, VNS, etc
American Society for Experimental NeuroTherapeutics | 15th Annual Meeting
American Society for Experimental NeuroTherapeutics | 15th Annual Meeting
NS Classification
Grid
External Implanted
Peripheral NS • TENS - Pn
• CI – Aud
• GES - GI
• SNS - GU
Central NS
• ECT – Dep
• TMS – Dep
• TNS – HA
• tDCS
• SCS – Pn
• OI –Vis
• VNS-Ep
• DBS-PD, Et, Ep
• CtS - Ep
Aud = Auditory; CI = Cochlear Implant; CtS = Cortical Stimulation; Dep = Depression; Ep = Epilepsy; Et = Essential Tremor; GI =
Gastrointestinal; GNS = GastricElectric Stimulation; GU = Genitorurological; HA = Headache; OI = Occipital Implant;PD =
Parkinson’s Dz; Pn = Pain/Analgesia; SCS = Spinal Cord Stimulation; SNS = Sacral Nerve Stimulation; TNS = Trigeminal Nerve
Stmulation; Vis = Vision
Current NS Treatment Modalities
What Are the Challenges?
• Clinical Trials: Demonstrating efficacy under
placebo conditions difficult due to blinding &
operator characteristics
• Long-term Stable Power Sources: Bigger batteries
vs. recharging for implantables
• Closed Loop vs. Open Loop Methodologies
• Support: Implantable Neurostim looking much
like pharma/biologic development: Time and $$$
Impact on Clinical Care and Practice
• NS has a long history of use in
medicine
• NS is a useful adjunctive tool in the
treatment of Neurologic conditions
• Several therapies have proven
efficacy and safety for various
disease conditions (eg, ET, Epilepsy)
• Much interest in new approaches:
• Implantable cortical and Deep Brain
Stim for Epilepsy + other conditions
• Non-invasive surface Trigeminal &
Vagal Stimulation
• Clinical trials, development
timelines can be challenging
• NS is still maturing
Thank You!
Contact Information:
scomfort@adaptixcs.com
References/Data/Graphic Sources
• tp://en.wikipedia.org/wiki/Electric_current
• antenna-theory.com; Physlink.com, various Google Images
• tp://www.burtonreport.com/infspine/NSHistNeurostimPar
tI.htm
• thefullwiki.org;
http://en.wikipedia.org/wiki/Electroconvulsive_therapy and
../Electroencephalography
• http://www.economist.com/blogs/dailychart/2011/10/comp
uting-power & letshavetheconversation.blogspot.com
• Osteoarthritis.about.com; Scientific American.com;
http://www.burtonreport.com/infspine/NSHistNeurostimPar
tI.htm
• Osteoarthritis.about.com; Medtronic.com; Cyberonics.com

Intro to Neurostimulation ASENT Feb 28 2013

  • 1.
    Neurostimulation: An Overview Thursday Feb28th Shaun Comfort, MD, MBA Adaptix Clinical Solutions, LLC American Society for Experimental NeuroTherapeutics | 15th Annual Meeting
  • 2.
    Disclosure(s) Consulting relationships with multiplePharma, Bio, and Medical Device Companies Equity: J&J American Society for Experimental NeuroTherapeutics | 15th Annual Meeting Other: I will discuss some currently unapproved Rx/Research technologies Learning Objectives • Outline the context & history of Neurostimulation • Identify several current Neurostim therapies
  • 3.
    The Brave NewWorld of Neurostimulation American Society for Experimental NeuroTherapeutics | 15th Annual Meeting
  • 4.
    Basic Definitions • FundamentalQuantity: Charge = Coulomb • Negative Charges: Electrons = 1.6 x 10-19 C • Moving Charges: Current = Amp {C/sec} • Charge Source (eg Battery): Voltage = Potential Energy/Ch = Volt {Joules/C} • Useful Relation: Ohm’s Law V = iR • Other Useful Terms: • Frequency = Cycles/sec {Hertz} American Society for Experimental NeuroTherapeutics | 15th Annual Meeting
  • 5.
    Basic Definitions, cont AmericanSociety for Experimental NeuroTherapeutics | 15th Annual Meeting
  • 6.
    Neurostimulation? • Neurostimulation? • Themodulation of nervous system activity by electrically activating individual or groups of neurons in the body, to achieve a clinical goal. • Can be achieved using: • Surface electrodes • Implantable electrodes • Indirect: Vector Force Fields (TMS) American Society for Experimental NeuroTherapeutics | 15th Annual Meeting
  • 7.
    Early Neurostimulation? • Firstapplication of neurostimulation: • Scribonius Largus, 65 AD • Torpedo fish (electric ray) • for relieving pain (Early TENS?) • Empirical findings that electricity applied to skin had interesting effects such as pain reduction American Society for Experimental NeuroTherapeutics | 15th Annual Meeting
  • 8.
    Coincidental Physics American Societyfor Experimental NeuroTherapeutics | 15th Annual Meeting
  • 9.
    American Society forExperimental NeuroTherapeutics | 15th Annual Meeting
  • 10.
    Faradization for PainRelief American Society for Experimental NeuroTherapeutics | 15th Annual Meeting
  • 11.
    The Good OldDays? • Early Faradization primitive and overly broad claims: • “Electreat” device – Willie Kent 1st person prosecuted under FD&C (1938) for Unsubstantiated Claims • Claims later limited to pain • However, this approach evolved into Transcutaneous Electrical Stimulation (TENS) used today for pain (eg, Shealy MD & Medtronics, 1970s) American Society for Experimental NeuroTherapeutics | 15th Annual Meeting
  • 12.
    Beyond Peripheral Faradization •Early 20th century - co-incident advances in electronics and medicine produced new tools for electrophysiology: ECG (1911), EEG (Berger, 1924) and therapy: ECT (Cerletti & Bini, 1938) American Society for Experimental NeuroTherapeutics | 15th Annual Meeting
  • 13.
    If That Isthe Past, Where Are We Today? • We are riding the 20th Century wave of Neuroscience + Moore’s Law • The results are: • Implantable micro-electronics • Open (VNS, DBS) - and Closed-loop (?) therapies • Wireless monitoring (eg, Implanted EEG) • Smart diagnostics (eg, ECG/EEG Interpretation) • Rapid advances in Neurosurgery, fMRI, etc American Society for Experimental NeuroTherapeutics | 15th Annual Meeting
  • 14.
    Moore’s Law To 1stapproximation, doubling of transistor density & computing efficiency every 18 months American Society for Experimental NeuroTherapeutics | 15th Annual Meeting
  • 15.
    SCS, TENS, tDCS,etc American Society for Experimental NeuroTherapeutics | 15th Annual Meeting
  • 16.
    TENS, TMS, DBS,VNS, etc American Society for Experimental NeuroTherapeutics | 15th Annual Meeting
  • 17.
    American Society forExperimental NeuroTherapeutics | 15th Annual Meeting NS Classification Grid External Implanted Peripheral NS • TENS - Pn • CI – Aud • GES - GI • SNS - GU Central NS • ECT – Dep • TMS – Dep • TNS – HA • tDCS • SCS – Pn • OI –Vis • VNS-Ep • DBS-PD, Et, Ep • CtS - Ep Aud = Auditory; CI = Cochlear Implant; CtS = Cortical Stimulation; Dep = Depression; Ep = Epilepsy; Et = Essential Tremor; GI = Gastrointestinal; GNS = GastricElectric Stimulation; GU = Genitorurological; HA = Headache; OI = Occipital Implant;PD = Parkinson’s Dz; Pn = Pain/Analgesia; SCS = Spinal Cord Stimulation; SNS = Sacral Nerve Stimulation; TNS = Trigeminal Nerve Stmulation; Vis = Vision Current NS Treatment Modalities
  • 18.
    What Are theChallenges? • Clinical Trials: Demonstrating efficacy under placebo conditions difficult due to blinding & operator characteristics • Long-term Stable Power Sources: Bigger batteries vs. recharging for implantables • Closed Loop vs. Open Loop Methodologies • Support: Implantable Neurostim looking much like pharma/biologic development: Time and $$$
  • 19.
    Impact on ClinicalCare and Practice • NS has a long history of use in medicine • NS is a useful adjunctive tool in the treatment of Neurologic conditions • Several therapies have proven efficacy and safety for various disease conditions (eg, ET, Epilepsy) • Much interest in new approaches: • Implantable cortical and Deep Brain Stim for Epilepsy + other conditions • Non-invasive surface Trigeminal & Vagal Stimulation • Clinical trials, development timelines can be challenging • NS is still maturing
  • 20.
  • 21.
    References/Data/Graphic Sources • tp://en.wikipedia.org/wiki/Electric_current •antenna-theory.com; Physlink.com, various Google Images • tp://www.burtonreport.com/infspine/NSHistNeurostimPar tI.htm • thefullwiki.org; http://en.wikipedia.org/wiki/Electroconvulsive_therapy and ../Electroencephalography • http://www.economist.com/blogs/dailychart/2011/10/comp uting-power & letshavetheconversation.blogspot.com • Osteoarthritis.about.com; Scientific American.com; http://www.burtonreport.com/infspine/NSHistNeurostimPar tI.htm • Osteoarthritis.about.com; Medtronic.com; Cyberonics.com