Brain Stimulation for Epilepsy

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Barbara Jobst

Disqualifiers: Recent RNS® implant

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

24 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of this treatment for epilepsy?

Research shows that electrical stimulation techniques like Functional Electrical Stimulation (FES) and Neuromuscular Electrical Stimulation (NMES) can improve muscle strength and function in conditions such as stroke and spinal cord injuries. While these studies focus on muscle and motor function, they suggest potential benefits of electrical stimulation in neurological conditions, which may be relevant for epilepsy treatment. ^{1 2 3 4 5}

Is electrical stimulation generally safe for humans?

Research indicates that electrical stimulation, such as peripheral nerve stimulation, is generally considered safe for humans, though specific safety data for chronic use is limited. Studies have reviewed safety aspects like stimulation parameters and charge limitations, especially for applications in the central nervous system. ^{4 6 7 8 9}

How does electrical stimulation treatment for epilepsy differ from other treatments?

Electrical stimulation for epilepsy is unique because it involves using electrical impulses to target specific areas of the brain or nervous system to reduce seizures, especially when medications or surgery are not effective. Unlike traditional drug treatments, it can be tailored to stimulate the brain at the site of seizure generation or network hubs, offering a more personalized approach. ^{10 11 12 13 14}

What is the purpose of this trial?

This study is designed to identify brain activity associated with good memory in subjects with a chronically implanted RNS® device and to study the effects of therapeutic stimulation for epilepsy on memory. This will be accomplished through analysis of ECoG data collected during memory encoding for short and long-term free recall as well as during navigation tasks.

Research Team

Barbara Jobst, MD

Principal Investigator

Dartmouth-Hitchcock Medical Center

Eligibility Criteria

This trial is for adults over 18 with epilepsy who have had an RNS® device implanted for at least 3 months. Participants must be able to consent and complete tasks as judged by the lead researcher.

Inclusion Criteria

Able to give informed consent

I have been diagnosed with epilepsy.

I can do the tasks required for the study, as per the lead researcher.

Exclusion Criteria

I had an RNS Neurostimulator implanted less than 3 months ago.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo therapeutic stimulation for epilepsy and memory tasks using the RNS® Neurostimulator

4 weeks

Multiple sessions for memory and navigation tasks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Electrical Stimulation

Trial Overview The study examines how brain activity linked to good memory functions in people with epilepsy using ECoG data from those with an RNS® device during memory and navigation tasks.

Participant Groups

Group I: RNS® Neurostimulator Experimental Treatment 1 Intervention

Subjects with pharmaceutically intractable seizures who have been implanted with a RNS® Neurostimulator.

Electrical Stimulation is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Electrical Stimulation for:

• Pain relief
• Muscle strengthening
• Rehabilitation after injury or surgery
• Neurological disorders
• Wound healing

Approved in European Union as Electrical Stimulation for:

• Pain management
• Muscle rehabilitation
• Neurological conditions
• Wound care

Approved in Canada as Electrical Stimulation for:

• Chronic pain
• Muscle atrophy
• Neurological rehabilitation
• Wound healing

Who Is Running the Clinical Trial?

Barbara Jobst

Lead Sponsor

Trials

1

Recruited

20+

NeuroPace

Industry Sponsor

Trials

11

Recruited

1,500+

Findings from Research

Recent research highlights that electrical stimulation of motor nerves can enhance muscle strength, reduce muscle spasms, and help manage spasticity, making it a valuable tool in physiotherapy.

Functional electrical stimulation (F.E.S.) is gaining traction as a key component in rehabilitation programs for patients with neurological impairments, suggesting its potential for broader application in therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motor stimulation with interferential currents. DE Domenico, GG., Strauss, GR.[2014]

A systematic review of literature on neuromuscular electrical stimulation (NMES) identified effective stimulation parameters for treating muscle impairments in conditions like stroke, ACL reconstruction, and knee osteoarthritis, based on a consensus among six Canadian PT experts.

The article serves as a comprehensive resource for physiotherapists, offering evidence-based recommendations and safety tips for the effective application of NMES in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromuscular Electrical Stimulation for Treatment of Muscle Impairment: Critical Review and Recommendations for Clinical Practice. Nussbaum, EL., Houghton, P., Anthony, J., et al.[2019]

In a study involving 10 adults, neuromuscular electrical stimulation (NMES) with a 200-microsecond pulse duration allowed participants to tolerate significantly greater muscle torques compared to a 50-microsecond pulse duration, indicating enhanced efficacy for muscle strengthening.

The findings suggest that medium pulse durations may be more effective for maximizing muscle torque responses, despite the common belief that shorter pulses are preferable due to lower pain thresholds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of maximum tolerated muscle torques produced by 2 pulse durations. Scott, WB., Causey, JB., Marshall, TL.[2014]

The study introduces a real-time functional electrical stimulation (FES) system that uses electromyography (eEMG) signals to predict joint torque, which is crucial for personalized rehabilitation in spinal cord injury (SCI) patients.

Testing on 3 able-bodied subjects and 3 SCI patients showed that both the Kalman filter and recurrent neural network (RNN) methods effectively estimated joint torque, with RNN being more computationally efficient, indicating potential for practical use in personalized neuroprosthetic control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-time estimation of FES-induced joint torque with evoked EMG : Application to spinal cord injured patients. Li, Z., Guiraud, D., Andreu, D., et al.[2019]

Neuroprostheses (NPs) have evolved from early muscle stimulators to advanced devices that can effectively activate paralyzed muscles, with functional electrical stimulation (FES) showing significant benefits in enhancing muscle function, particularly in conditions like foot drop.

Recent advancements in technology have made these devices more convenient and reliable, leading to improved therapeutic outcomes, although challenges remain in enhancing upper limb function compared to lower limbs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motor Neuroprostheses. Prochazka, A.[2019]

In a study involving 20 healthy males, neuromuscular electrical stimulation (NMES) led to a significant decrease in maximal voluntary contraction (MVC) torque after just one sequence, indicating early onset of neuromuscular fatigue.

Cortical activity in both the primary motor (M1) and primary somatosensory (S1) areas declined during NMES, suggesting that the motor cortex is involved in the loss of force, but the decrease in motor output is not due to increased inhibition from the sensory cortex.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cortical motor output decreases after neuromuscular fatigue induced by electrical stimulation of the plantar flexor muscles. Alexandre, F., Derosiere, G., Papaiordanidou, M., et al.[2015]

Extraneural electrodes are more stable for long-term use compared to intraneural electrodes, which is important for the safety of chronic electrical stimulation applications.

Current guidelines suggest that chronic stimulation should be kept below 30 Hz and effective stimulation time below 50% to minimize risks, but more comprehensive data is needed to establish safe stimulation protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of long-term electrical peripheral nerve stimulation: review of the state of the art. Günter, C., Delbeke, J., Ortiz-Catalan, M.[2021]

A study involving 713 chronic pain patients showed that fixed-site high-frequency transcutaneous electrical nerve stimulation (FS-TENS) significantly reduced pain intensity and interference with daily activities and mood after 60 days of use.

The effectiveness of FS-TENS improved with increased usage, with 57.1% of high-utilization users experiencing clinically meaningful reductions in pain interference, highlighting the importance of consistent application for optimal results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of fixed-site high-frequency transcutaneous electrical nerve stimulation in chronic pain: a large-scale, observational study. Kong, X., Gozani, SN.[2022]

Vagus nerve stimulation is the only method of electrical stimulation for epilepsy that has undergone large, controlled clinical trials, showing its potential as a therapy for intractable epilepsy.

Other forms of electrical stimulation, such as targeting the anterior nuclei of the thalamus and cortical stimulation, are still in the trial phase and are considered experimental, indicating that more research is needed to establish their safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experimental Electrical Stimulation Therapy for Epilepsy. Oommen, J., Morrell, M., Fisher, RS.[2022]

Brain stimulation techniques, such as responsive neurostimulation and advanced vagus nerve stimulation, are being used to help epilepsy patients who do not respond well to medications, targeting either the seizure origin or key brain areas to reduce seizure severity.

While new transcutaneous stimulation methods are emerging, their effectiveness is still uncertain, highlighting the need for careful evaluation of different neuromodulatory strategies in treating epilepsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brain stimulation as a neuromodulatory epilepsy therapy. Schulze-Bonhage, A.[2017]

References

1. Australia pubmed.ncbi.nlm.nih.gov

Motor stimulation with interferential currents. [2014]

2. Canada pubmed.ncbi.nlm.nih.gov

Neuromuscular Electrical Stimulation for Treatment of Muscle Impairment: Critical Review and Recommendations for Clinical Practice. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Dipolar cortico-muscular electrical stimulation: a novel method that enhances motor function in both - normal and spinal cord injured mice. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Comparison of maximum tolerated muscle torques produced by 2 pulse durations. [2014]

5. England pubmed.ncbi.nlm.nih.gov

Real-time estimation of FES-induced joint torque with evoked EMG : Application to spinal cord injured patients. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Motor Neuroprostheses. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Cortical motor output decreases after neuromuscular fatigue induced by electrical stimulation of the plantar flexor muscles. [2015]

8. England pubmed.ncbi.nlm.nih.gov

Safety of long-term electrical peripheral nerve stimulation: review of the state of the art. [2021]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Effectiveness of fixed-site high-frequency transcutaneous electrical nerve stimulation in chronic pain: a large-scale, observational study. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

[Treatment of epilepsy: peripheral and central stimulation techniques]. [2021]

11. Austria pubmed.ncbi.nlm.nih.gov

Brain stimulation for epilepsy. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Experimental Electrical Stimulation Therapy for Epilepsy. [2022]

13. Germany pubmed.ncbi.nlm.nih.gov

[Electric brain stimulation for epilepsy therapy]. [2018]

14. England pubmed.ncbi.nlm.nih.gov

Brain stimulation as a neuromodulatory epilepsy therapy. [2017]