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

15 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this study is to verify whether electrical stimulation of the cervical spinal cord can activate muscles of the arm and hand in people with hemiplegia following stroke. Participants will undergo a surgical procedure to implant a system which provides epidural electrical stimulation (EES) of the cervical spinal cord. Researchers will quantify the ability of EES to recruit arm and hand muscles and produce distinct kinematic movements. The implant will be removed after less than 30 days. Results of this study will provide the foundation for future studies evaluating the efficacy of a minimally-invasive neuro-technology that can be used in clinical neurorehabilitation programs to restore upper limb motor function in people with subcortical strokes, thereby increasing independence and quality of life.

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 data supports the effectiveness of the treatment Epidural electrical stimulation (EES) of the cervical spinal cord for stroke recovery?

Research shows that epidural electrical stimulation of the spinal cord can help improve motor function in animals with spinal cord injuries, particularly in their ability to reach and grasp. This suggests that similar stimulation might help people recover movement after a stroke. ^{1 2 3 4 5}

Is spinal cord stimulation generally safe for humans?

Spinal cord stimulation, including epidural electrical stimulation, has been used safely for decades to treat various conditions. While early methods had some risks like infection and spinal cord compression, modern techniques have improved safety by using epidural placement to minimize complications. ^{3 6 7 8 9}

How does the treatment Epidural electrical stimulation (EES) of the cervical spinal cord differ from other treatments for stroke recovery?

Epidural electrical stimulation (EES) of the cervical spinal cord is unique because it directly stimulates the spinal cord to improve motor function, which is different from traditional stroke treatments that often focus on medication or physical therapy. This method has shown promise in improving motor control by activating specific spinal networks, potentially offering a new way to enhance recovery of arm and hand movements after a stroke. ^{1 2 4 10 11}

Research Team

Lee Fisher, PhD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Advances in Spinal Cord Neuromodulation: The Integration of Neuroengineering, Computational Approaches, and Innovative Conceptual Frameworks. [2023]

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

Electrical neuromodulation of the cervical spinal cord facilitates forelimb skilled function recovery in spinal cord injured rats. [2018]

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

Review of spinal cord stimulation for disorders of consciousness. [2023]

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

Intraoperative electrical stimulation of the human dorsal spinal cord reveals a map of arm and hand muscle responses. [2023]

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

The feasibility of using exoskeletal-assisted walking with epidural stimulation: a case report study. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Characterization and applications of evoked responses during epidural electrical stimulation. [2023]

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

Spinal Cord Stimulation Provides Pain Relief with Improved Psychosocial Function: Results from EMP3OWER. [2018]

8. India pubmed.ncbi.nlm.nih.gov

Epidural electrical stimulation effectively restores locomotion function in rats with complete spinal cord injury. [2021]

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

Postsurgical pathologies associated with intradural electrical stimulation in the central nervous system: design implications for a new clinical device. [2022]

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

Targeting Lumbar Spinal Neural Circuitry by Epidural Stimulation to Restore Motor Function After Spinal Cord Injury. [2018]

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

Selective Recruitment of Arm Motoneurons in Nonhuman Primates Using Epidural Electrical Stimulation of the Cervical Spinal Cord. [2020]