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FDA Indications for Use
1. Management and symptomatic relief of chronic (long term)
intractable pain
2. Adjunctive treatment of acute, post-traumatic pain
3. Adjunctive treatment of post-surgical pain
4. Relaxation of muscle spasms
5. Prevention or retardation of tissue atrophy
6. Increasing or improving circulation
7. Neuromuscular reeducation
8. Immediate post-surgical use to prevent phlebothrombosis
9. Maintaining or increasing range of motion
FDA Indications for Use
1. Management and symptomatic relief of chronic (long term)
intractable pain
2. Adjunctive treatment of acute, post-traumatic pain
3. Adjunctive treatment of post-surgical pain
4. Relaxation of muscle spasms
5. Prevention or retardation of tissue atrophy
6. Increasing or improving circulation
7. Neuromuscular reeducation
8. Immediate post-surgical use to prevent phlebothrombosis
9. Maintaining or increasing range of motion
Electric Signaling Effects
Neuron Function
Imitation
Exhaustion
Interruption
Signal Competition: (gate control theory)
Relaxation: (muscle – referred pain inhibition)
Hormonal Response: (neuropeptide release)
Ionic Movement: (enzyme / substrate orientation)
Membrane Response: (sustained depolarization)
Noise Effect: (signal scramble, no re-excitation)
Self-Organizing Effect: (post-hyperactivity inhibition)
Quantum Effect: (vector potential – polarization effect)
Mechanism Description
Electric Signaling Effects
Signal Competition (gate control theory)
Large diameter afferent nerve fibers carry signals faster than the small unmyelinated
pain fibers, creating activity in the inhibitory circuits at the dorsal horn “gate”. This
blocks the perception of pain. (Melzack and Wall)
Mechanism Description
Electric Signaling Effects
Relaxation / Anti-Spasmodic Effects
Muscle Function :
Relaxation and spasm release decreases referred pain.
Neuron Function - Exhaustion:
Higher-rate electrical signals producing repeated action impulse at a rate which
cannot be effectively followed by the human nervous system. This depletes the
synaptic transmitters necessary for continued action potential propagation.
Mechanism Description
Electric Signaling Effects
Hormonal Response: (neuropeptides)
Increase in Dopamine Concentration:
Electric Signaling (with specific parameters) significantly increases dopamine
concentration (pain inhibitory transmitter)
Decrease in Norepinephrine, Serotonin:
Electric signaling (with specific parameters) decreases norepinephrine and serotonin
(excitatory transmitters).
Mechanism Description
Electric Signaling Effects
Hormone Response
Endogenous Opiate Release:
Electric signaling induces the release of powerful endogenous opiates, like
enkephalins and endorphins (morphine effect)
ACTH Secretion:
Electric signaling induces ACTH secretion (MSH hormone). ACTH secretion-induced
melanin becomes insulators when electric cell signals exceed the sensory or motor
threshold (signal inhibition).
Mechanism Description
Electric Signaling Effects
Ion Movement
Pain Mediator (metabolite) Response:
Under the influence of alternating–polarity electric fields, ion movement balances
metabolite concentration differences (pH).
Metabolic Facilitation:
A direct Influence on enzyme/substrate activity, which increases the probability of
hormone/ligand “favorable” orientation, transition state and the breakdown of pain
producing metabolites.
Mechanism Description
Electric Signaling Effects
Cell Membrane Response
Sustained Membrane Depolarization:
Multiple electric signals, which fall within the refractory period of the cell membrane
induce sustained depolarization…inhibiting the transport of pain signals along the
nerve axon.
Second Messenger Formation (cAMP):
An influence on voltage-gated channels, initiating second messenger formation
(cAMP). This directs all “cell-specific” activity…activates regenerative processes and
the repair of the cell membrane.
Mechanism Description
Electric Signaling Effects
Noise Effect
Scrambling Out the Perception of Pain:
Electric stimulation produces noise signals that excite a large area of nerves, self-
focused nerve conduction cannot stabilize…the signal is diffused…no lateral
occurs, re-excitation is impossible.
Disturbance of the Self-Organizing Structure:
Chaotic self-organizing is a decisional factor of signal transmission in living systems
(neuronal pool)...spatio-temporal order is chaotically rearranged…neuronal pool
transmission is altered or inhibited.
Mechanism Description
Electric Signaling Effects
Quantum Effects
Cell Membrane Processes:
All microscopic events (cell membrane processes, biochemical events, etc. are
determined by quantum-mechanical rules… electromagnetic potentials determine
processes, not the field
Vector Potential:
Change in vector potential effectively alters the quantum bio-processes…all of the
micro-reactions are dynamical. Vector potential determines water polarization states
(sodium channel).
Mechanism Description
Electric Signaling Effects
Stimulatory Class
The physiological effects induced by repeated action potentials in cells
(depolarization and subsequent repolarization activitexcitabley).
Multi-Facilitation Class
The physiological effects induced without action potentials (NO
depolarization and repolarization activity). These include biochemical
effects.
Electric Signaling Classifications
Counter-irritation
Neuropeptide Release
Stimulatory Class
Signal Example - Analgesia
Neuron Block (sustained depolarization)
Pain Mediator (metabolite) Redistribution
Cell Membrane Repair (cAMP)
Multi-Facilitory Class
Signal Example - Analgesia
Signal Energy Outcomes
pH normalization
Hormone/ligand activity imitation
Trophic improvement
Improved membrane permeability
Immune system support (Gap Junction)
via improved cell-to-cell communication
Activation of Regeneration…
Cell repair and normalization (cAMP)
cAMP Normalization
Up to 500% increase in intercellular cAMP via sustained cell membrane
depolarization
Clarence Cone MD, Ph.D. University of Virginia
Post-Hyperactivity Depression
Prolonged, hypo-excitable state of nerves arising from relatively short duration
electric signaling treatment
Robert Schwartz, MD Medical University of South Carolina
Signal Energy Outcomes
Action Potential Chart
Spread-Spectrum Frequency Hopping Oscilloscope
Tracing
Live Signal
Signal Rendering

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FDA Approved Uses of Electric Stimulation

  • 1.
  • 2. FDA Indications for Use 1. Management and symptomatic relief of chronic (long term) intractable pain 2. Adjunctive treatment of acute, post-traumatic pain 3. Adjunctive treatment of post-surgical pain 4. Relaxation of muscle spasms 5. Prevention or retardation of tissue atrophy 6. Increasing or improving circulation 7. Neuromuscular reeducation 8. Immediate post-surgical use to prevent phlebothrombosis 9. Maintaining or increasing range of motion
  • 3. FDA Indications for Use 1. Management and symptomatic relief of chronic (long term) intractable pain 2. Adjunctive treatment of acute, post-traumatic pain 3. Adjunctive treatment of post-surgical pain 4. Relaxation of muscle spasms 5. Prevention or retardation of tissue atrophy 6. Increasing or improving circulation 7. Neuromuscular reeducation 8. Immediate post-surgical use to prevent phlebothrombosis 9. Maintaining or increasing range of motion
  • 4. Electric Signaling Effects Neuron Function Imitation Exhaustion Interruption
  • 5. Signal Competition: (gate control theory) Relaxation: (muscle – referred pain inhibition) Hormonal Response: (neuropeptide release) Ionic Movement: (enzyme / substrate orientation) Membrane Response: (sustained depolarization) Noise Effect: (signal scramble, no re-excitation) Self-Organizing Effect: (post-hyperactivity inhibition) Quantum Effect: (vector potential – polarization effect) Mechanism Description Electric Signaling Effects
  • 6. Signal Competition (gate control theory) Large diameter afferent nerve fibers carry signals faster than the small unmyelinated pain fibers, creating activity in the inhibitory circuits at the dorsal horn “gate”. This blocks the perception of pain. (Melzack and Wall) Mechanism Description Electric Signaling Effects
  • 7. Relaxation / Anti-Spasmodic Effects Muscle Function : Relaxation and spasm release decreases referred pain. Neuron Function - Exhaustion: Higher-rate electrical signals producing repeated action impulse at a rate which cannot be effectively followed by the human nervous system. This depletes the synaptic transmitters necessary for continued action potential propagation. Mechanism Description Electric Signaling Effects
  • 8. Hormonal Response: (neuropeptides) Increase in Dopamine Concentration: Electric Signaling (with specific parameters) significantly increases dopamine concentration (pain inhibitory transmitter) Decrease in Norepinephrine, Serotonin: Electric signaling (with specific parameters) decreases norepinephrine and serotonin (excitatory transmitters). Mechanism Description Electric Signaling Effects
  • 9. Hormone Response Endogenous Opiate Release: Electric signaling induces the release of powerful endogenous opiates, like enkephalins and endorphins (morphine effect) ACTH Secretion: Electric signaling induces ACTH secretion (MSH hormone). ACTH secretion-induced melanin becomes insulators when electric cell signals exceed the sensory or motor threshold (signal inhibition). Mechanism Description Electric Signaling Effects
  • 10. Ion Movement Pain Mediator (metabolite) Response: Under the influence of alternating–polarity electric fields, ion movement balances metabolite concentration differences (pH). Metabolic Facilitation: A direct Influence on enzyme/substrate activity, which increases the probability of hormone/ligand “favorable” orientation, transition state and the breakdown of pain producing metabolites. Mechanism Description Electric Signaling Effects
  • 11. Cell Membrane Response Sustained Membrane Depolarization: Multiple electric signals, which fall within the refractory period of the cell membrane induce sustained depolarization…inhibiting the transport of pain signals along the nerve axon. Second Messenger Formation (cAMP): An influence on voltage-gated channels, initiating second messenger formation (cAMP). This directs all “cell-specific” activity…activates regenerative processes and the repair of the cell membrane. Mechanism Description Electric Signaling Effects
  • 12. Noise Effect Scrambling Out the Perception of Pain: Electric stimulation produces noise signals that excite a large area of nerves, self- focused nerve conduction cannot stabilize…the signal is diffused…no lateral occurs, re-excitation is impossible. Disturbance of the Self-Organizing Structure: Chaotic self-organizing is a decisional factor of signal transmission in living systems (neuronal pool)...spatio-temporal order is chaotically rearranged…neuronal pool transmission is altered or inhibited. Mechanism Description Electric Signaling Effects
  • 13. Quantum Effects Cell Membrane Processes: All microscopic events (cell membrane processes, biochemical events, etc. are determined by quantum-mechanical rules… electromagnetic potentials determine processes, not the field Vector Potential: Change in vector potential effectively alters the quantum bio-processes…all of the micro-reactions are dynamical. Vector potential determines water polarization states (sodium channel). Mechanism Description Electric Signaling Effects
  • 14. Stimulatory Class The physiological effects induced by repeated action potentials in cells (depolarization and subsequent repolarization activitexcitabley). Multi-Facilitation Class The physiological effects induced without action potentials (NO depolarization and repolarization activity). These include biochemical effects. Electric Signaling Classifications
  • 15.
  • 17. Neuron Block (sustained depolarization) Pain Mediator (metabolite) Redistribution Cell Membrane Repair (cAMP) Multi-Facilitory Class Signal Example - Analgesia
  • 18. Signal Energy Outcomes pH normalization Hormone/ligand activity imitation Trophic improvement Improved membrane permeability Immune system support (Gap Junction) via improved cell-to-cell communication Activation of Regeneration… Cell repair and normalization (cAMP)
  • 19. cAMP Normalization Up to 500% increase in intercellular cAMP via sustained cell membrane depolarization Clarence Cone MD, Ph.D. University of Virginia Post-Hyperactivity Depression Prolonged, hypo-excitable state of nerves arising from relatively short duration electric signaling treatment Robert Schwartz, MD Medical University of South Carolina Signal Energy Outcomes
  • 21. Spread-Spectrum Frequency Hopping Oscilloscope Tracing Live Signal Signal Rendering