Spinal Cord Stimulation for Stroke Recovery

Overseen By Lee Fisher, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Lee Fisher, PhD

Must not be taking: Anticoagulants, Anti-spasticity, Anti-epileptics

Disqualifiers: Neurological conditions, Cancer, Severe cardiac, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether electrical stimulation of the spinal cord can improve arm and hand movement for individuals with post-stroke mobility challenges. Participants will temporarily receive a small implanted device that delivers electrical signals to their spinal cord, aiming to activate muscles and enhance movement. This process, known as epidural electrical stimulation (EES) of the cervical spinal cord, is being tested for its potential to aid recovery. The study targets individuals who experienced a stroke over six months ago and continue to have arm movement issues. This research aims to pave the way for new treatments that could simplify everyday tasks for stroke survivors. As an unphased trial, it offers participants the chance to contribute to pioneering research that could lead to innovative stroke recovery treatments.

Will I have to stop taking my current medications?

Yes, if you are taking anticoagulant (blood-thinning), anti-spasticity (muscle relaxant), or anti-epileptic (seizure prevention) medications, you will need to stop them for the duration of the study.

What prior data suggests that this spinal cord stimulation technique is safe for stroke recovery?

Research has shown that electrical stimulation on the neck area of the spinal cord may help individuals with long-term weakness on one side of the body after a stroke. In one study, two participants experienced immediate improvement in arm and hand movement with this stimulation, suggesting the treatment might be safe for humans, at least in the short term.

Another study examined the safety of similar spinal cord stimulation methods and found them to be safe and effective for improving arm and hand functions in individuals with spinal cord injuries. Although this differs from stroke, it provides some evidence of the procedure's safety for humans.

While more research is needed to confirm these findings, early results suggest that this type of electrical stimulation could be a promising and safe option for stroke recovery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional stroke recovery treatments that often focus on physical therapy and medication to manage symptoms, Epidural Electrical Stimulation (EES) of the cervical spinal cord offers a novel approach. EES works by directly stimulating the spinal cord, potentially enhancing the brain's ability to rewire itself and improve motor functions in the upper extremities. Researchers are excited about EES because it targets the spinal cord's neural pathways, offering a new way to restore movement and function more effectively than current methods. This innovative technique could lead to significant improvements in recovery times and outcomes for stroke survivors.

What evidence suggests that epidural electrical stimulation is effective for stroke recovery?

Research has shown that applying electrical signals to the neck area of the spinal cord can improve arm and hand movement in stroke survivors. This trial will examine the effects of epidural electrical stimulation (EES) of the cervical spinal cord on stroke recovery. Studies have found that this treatment can quickly enhance strength and control in the upper limbs. In some cases, participants continued to experience benefits even after the treatment ended. Another study found that this method can safely and effectively improve hand and arm function. These early results suggest that spinal cord stimulation might be a promising approach to help stroke survivors regain movement and independence. ^{1 2 3 6 7}

Who Is on the Research Team?

Lee Fisher, PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for adults aged 21-70 who've had a stroke at least 6 months ago, resulting in arm weakness but not complete paralysis. They should be able to participate actively and not have severe diseases, cognitive issues, or be pregnant. They can't take certain medications or have implants that could interfere with the study.

Inclusion Criteria

I had a stroke over 6 months ago that affected my arm's movement.

I am between 21 and 70 years old.

Your Fugl-Meyer scale score is not between 7 and 50.

Exclusion Criteria

Presence of any implanted medical devices.

I am mentally capable of understanding and signing a consent form.

I do not have any serious illness or cognitive issues that would prevent me from participating in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Implantation

Participants undergo a surgical procedure to implant a system for epidural electrical stimulation of the cervical spinal cord

1 week

Treatment

Participants receive epidural electrical stimulation to assess motor potentials and kinematic movements

4 weeks

Multiple visits for assessments and stimulation sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, including removal of the implant

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Epidural electrical stimulation (EES) of the cervical spinal cord

Trial Overview Researchers are testing if electrical stimulation of the spinal cord can help activate arm and hand muscles in stroke survivors with hemiplegia. Participants will get a temporary implant to deliver this stimulation and see if it improves their ability to move their limbs.

How Is the Trial Designed?

Group I: Epidural electrical stimulation of the cervical spinal cord Experimental Treatment 1 Intervention

Individuals with prior subcortical stroke and hemiparesis of the upper extremity.

Who Is Running the Clinical Trial?

Lee Fisher, PhD

Lead Sponsor

Trials

4

Recruited

70+

Marco Capogrosso

Lead Sponsor

Trials

3

Recruited

40+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Published Research Related to This Trial

Spinal cord stimulation has been effectively used for various conditions, including chronic pain syndromes, but the method has evolved from subdural to epidural placement to enhance safety and reduce surgical complications.

The review highlights potential complications from early subdural stimulation techniques, such as infection and neurotoxicity, which can inform the development of a new subdural stimulation approach aimed at improving both safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postsurgical pathologies associated with intradural electrical stimulation in the central nervous system: design implications for a new clinical device. Gibson-Corley, KN., Flouty, O., Oya, H., et al.[2022]

Spinal cord epidural stimulation (SCES) combined with exoskeletal-assisted walking (EAW) showed promising results in enhancing motor control for a person with complete C7 spinal cord injury, reducing the need for swing assistance from 100% to 35% over 12 weeks.

The approach led to 573 unassisted steps, indicating improved muscle activation and potential for greater independence in movement, suggesting that SCES with EAW could be a practical rehabilitation method for individuals with spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The feasibility of using exoskeletal-assisted walking with epidural stimulation: a case report study. Gorgey, AS., Gill, S., Holman, ME., et al.[2021]

Epidural electrical stimulation (EES) has been used therapeutically for many years, but understanding its exact mechanism of action remains unclear; this study investigates the evoked compound action potential (ECAP) as a measure of local neural activity during EES.

The research demonstrates that the ECAP component in epidural spinal recordings can help detect lead migration, a potential complication that may affect the effectiveness of EES therapy, and shows concurrent activation of back and leg muscles during stimulation, which could inform future EES system designs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterization and applications of evoked responses during epidural electrical stimulation. Verma, N., Romanauski, B., Lam, D., et al.[2023]

Spinal cord stimulation (SCS) is evolving from a treatment for intractable pain to a potential method for restoring function after spinal cord injuries, driven by advances in understanding spinal cord lesions and compensatory mechanisms.

New SCS strategies, like spatiotemporal neuromodulation, show promise but require intensive rehabilitation techniques to be effective, highlighting the need for well-designed clinical trials to evaluate safety and efficacy in real-world applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in Spinal Cord Neuromodulation: The Integration of Neuroengineering, Computational Approaches, and Innovative Conceptual Frameworks. Pradat, PF., Hayon, D., Blancho, S., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36807682/

Epidural stimulation of the cervical spinal cord for post-stroke ... A first-in-human study using electrical stimulation of cervical spinal circuits to facilitate arm and hand motor control in chronic post-stroke hemiparesis.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10291889/

EPIDURAL STIMULATION OF THE CERVICAL SPINAL ... In this study we report preliminary evidence from two participants showing that continuous SCS targeting cervical dorsal roots could immediately improve upper ...

3. nature.com nature.com/articles/s41591-024-02940-9

Non-invasive spinal cord electrical stimulation for arm and ... These results demonstrate the safety and efficacy of ARC EX Therapy to improve hand and arm functions in people living with cervical SCI.

4. medrxiv.org medrxiv.org/content/10.1101/2022.04.11.22273635.full

Epidural stimulation of the cervical spinal cord improves ... Overall, stimulation improved strength, kinematics, and functional performance. Unexpectedly, both participants retained some of these ...

5. withpower.com withpower.com/trial/phase-stroke-2-2021-e95b9

Spinal Cord Stimulation for Stroke Recovery Spinal cord epidural stimulation (SCES) combined with exoskeletal-assisted walking (EAW) showed promising results in enhancing motor control for a person with ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06867809

NCT06867809 | Spine and Brain Stimulation for Movement ... Stimulation of the spinal cord and brain represents a new experimental therapy that may have potential to restore movement after spinal cord injury.

7. neurologyadvisor.com neurologyadvisor.com/news/epidural-spinal-cord-stimulation-improve-poststroke-motor-deficits/

Epidural Spinal Cord Stimulation Helps Improve Poststroke ... Epidural spinal cord stimulation may help patients with poststroke hemiparesis regain function and even retain some motor function ...