Spinal Cord Stimulation + Rehabilitation for Stroke

(HARNESS Trial)

Overseen By Fatma Inanici

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Must not be taking: Benzodiazepines, Anticoagulants, Antiepileptics, others

Disqualifiers: Hemorrhagic stroke, Multiple strokes, others

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

Compensation: Varies

Number of Visits: 18

Duration: 6 weeks

6 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether non-invasive electrical spinal cord stimulation, combined with activity-based rehabilitation, can improve hand and arm function in stroke survivors. The researchers aim to determine if these combined treatments can enhance recovery and maintain improvements after treatment ends. Suitable participants include those who have experienced a single ischemic stroke resulting in arm and hand weakness, are at least six months post-stroke, and can attend therapy sessions three times a week. As an unphased trial, this study provides a unique opportunity to contribute to pioneering research that could enhance stroke recovery therapies.

Will I have to stop taking my current medications?

Yes, you may need to stop taking certain medications. The trial excludes participants who are taking baclofen more than 30 mg/day, have changed their baclofen dose within four weeks before enrollment, or are receiving benzodiazepines, dantrolene, tizanidine, anticoagulant, or antiepileptic medication.

What prior data suggests that this spinal cord stimulation and rehabilitation protocol is safe for stroke recovery?

Research has shown that gentle electrical stimulation on the spinal cord, combined with rehabilitation exercises, is generally safe for people with spinal cord injuries. Studies have found that this method is well-tolerated and does not cause major side effects. For instance, one study showed it improved arm and hand movements in patients with spinal cord injuries. Another study confirmed that this treatment is safe for the heart when combined with rehabilitation. These results suggest that this type of stimulation could also safely aid recovery in other conditions, such as after a stroke. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they offer a fresh approach to stroke rehabilitation. Unlike standard therapies that focus solely on physical exercises and medication, this trial combines Activity Based Rehabilitation with Non-invasive Electrical Spinal Cord Stimulation. This innovative combination aims to enhance recovery by using electrical pulses to potentially boost nerve activity and improve motor function, offering hope for quicker and more effective rehabilitation. The non-invasive nature of the spinal cord stimulation also means it is safer and more accessible, potentially leading to better outcomes for stroke survivors.

What evidence suggests that this trial's treatments could be effective for stroke recovery?

Research has shown that gentle electrical stimulation on the spinal cord, combined with physical rehabilitation exercises, can improve hand and arm function. In this trial, participants will be assigned to one of two treatment arms. One arm will receive Activity Based Rehabilitation alone, involving intensive, progressive, functional task practice. The other arm will receive Non-invasive Electrical Spinal Cord Stimulation paired with Activity Based Rehabilitation. Previous studies demonstrated that people with long-term spinal cord injuries in the neck area regained some voluntary movement in muscles that were previously paralyzed. These improvements in hand and arm function persisted for months after the electrical stimulation ended. Additionally, transcutaneous spinal cord stimulation, which sends electrical pulses through the skin, has effectively helped people recover movement. These findings suggest that this combined approach might also benefit those recovering from a stroke. ^{2 4 6 7 8}

Who Is on the Research Team?

Chet Moritz, PhD

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

This trial is for adults who had an ischemic stroke at least six months ago, with moderate to mild arm and hand movement difficulties. They must be medically stable, able to understand English, have social support for attending sessions thrice weekly, not pregnant or agree to use contraception, and have a single documented stroke causing one-sided weakness.

Inclusion Criteria

My arm and hand movement ability is moderately impaired.

It has been over 6 months since my stroke.

Medically and neurologically stable, as determined by medical history and documented physical examination

Exclusion Criteria

I had a seizure more than a month after having a stroke.

I have severe stiffness in my hand and arm joints.

I am currently taking medication for anxiety, muscle spasms, blood thinning, or seizures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive non-invasive electrical spinal cord stimulation combined with activity-based rehabilitation. Sessions occur three times per week, 90 minutes per session for six weeks.

6 weeks

18 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with repeated measurements every two weeks throughout the study.

8 months

What Are the Treatments Tested in This Trial?

Interventions

• Activity Based Rehabilitation
• Non-invasive Electrical Spinal Cord Stimulation

Trial Overview The study tests if non-invasive electrical spinal cord stimulation combined with activity-based rehabilitation can improve hand and arm function after a stroke. It involves placing surface electrodes on the neck for stimulation and practicing functional tasks as part of rehabilitation.

How Is the Trial Designed?

Group I: Non-invasive Electrical Spinal Cord Stimulation + Activity Based Rehabilitation Experimental Treatment 2 Interventions

Non-invasive electrical spinal cord stimulation will be performed using surface electrodes placed over the skin of the neck. Biphasic rectangular pulses of 1 millisecond per phase duration will be delivered with a 10 kiloHertz overlapping frequency and between 20-120 Hertzz burst frequency. Non-invasive electrical spinal cord stimulation will be paired with Activity Based Rehabilitation sessions. Stimulation plus rehabilitation sessions will be three times per week, 90 minutes per session for six weeks (total of 18 sessions).

Group II: Activity Based Rehabilitation Active Control 1 Intervention

Activity Based Rehabilitation is comprised of intensive, progressive, functional task practice. The protocol consists of repetitive activities of gross upper limb movement, isolated finger movements, bimanual task performance, simple and complex pinch, and grip performance. Several activities with various difficulty levels are designated for each category, and the participant will perform 1-2 activities within each category in each rehabilitation session. Rehabilitation sessions will be three times per week, 90 minutes per session for six weeks (total of 18 sessions).

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11108781/

Non-invasive spinal cord electrical stimulation for arm and ... Non-invasive spinal cord electrical stimulation for arm and hand function in chronic tetraplegia: a safety and efficacy trial

2. biomedical-engineering-online.biomedcentral.com biomedical-engineering-online.biomedcentral.com/articles/10.1186/s12938-024-01231-1

Noninvasive spinal stimulation improves walking in chronic ... This case series study aims to investigate the effectiveness of transcutaneous spinal cord stimulation (tSCS) in enhancing walking ability of persons with ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12548825/

Protocol for a Systematic Review and Meta-Analysis - PMC Transcutaneous spinal cord stimulation (tSCS) has emerged as a promising neuromodulation technique for enhancing motor recovery and walking ...

4. neuromodulationjournal.org neuromodulationjournal.org/article/S1094-7159(24)00111-9/fulltext

Non-invasive Transcutaneous Spinal Cord Stimulation ... This study analyzes the stimulation parameters implemented during two successful trials that used non-invasive transcutaneous spinal cord stimulation (tSCS)

5. neurology.org neurology.org/doi/10.1212/CPJ.0000000000200537

Home-Based Noninvasive Spinal Cord Stimulation Safely ... Another study involving 6 participants with chronic cervical SCI also showed sustained improvements in hand and arm function persisting 3- to 6- ...

6. 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.

7. sciencedirect.com sciencedirect.com/science/article/pii/S1878747925000066

Cardiovascular safety of transcutaneous spinal cord ... This study supports the safety profile of cervical tSCS paired with rehabilitation in individuals with cervical spinal cord injury.

8. frontiersin.org frontiersin.org/journals/rehabilitation-sciences/articles/10.3389/fresc.2021.740307/full

Transcutaneous Electrical Spinal Cord Stimulation to ... The primary objective of this pilot study was to evaluate the safety and feasibility of using TSCS in a clinical setting to promote recovery ...