1. Neurostimulation:
An Overview
Thursday Feb 28th
Shaun Comfort, MD, MBA
Adaptix Clinical Solutions, LLC
American Society for Experimental NeuroTherapeutics | 15th Annual Meeting
2. 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
3. The Brave New World of
Neurostimulation
American Society for Experimental NeuroTherapeutics | 15th Annual Meeting
4. 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
6. 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
7. 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
10. Faradization for Pain Relief
American Society for Experimental NeuroTherapeutics | 15th Annual Meeting
11. 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
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 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
14. Moore’s Law
To 1st approximation, 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 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
18. 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 $$$
19. 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
