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

Trial Summary

What is the purpose of this trial?

The recovery from a stroke is often incomplete. It is the leading cause of acquired permanent disability in the adult population. Persistent functional loss of the hand and arm contributes significantly to disability. However, the current standard of care to treat hand and arm movements are inadequate. There is an urgent need for innovative and effective therapies for recovery of the upper limb after stroke. Growing evidence shows that electrical spinal cord stimulation, combined with activity-dependent rehabilitation, enables voluntary movement of paralyzed muscles in some neurologic disorders, such as spinal cord injury. The investigators hypothesize that spinal networks that lost control after stroke can be activated by non-invasive electrical stimulation of the spinal cord to improve functional recovery. The aims of the study are: 1. to determine the improvements in hand and arm function that result from the combined application of non-invasive spinal stimulation and activity-based rehabilitation. Surface electrodes placed over the skin of the neck will be used for non-invasive electrical stimulation of the spinal cord. Functional task practice will be used for activity-dependent rehabilitation, 2. to evaluate long-lasting benefits to hand and arm function that persist beyond the period of spinal stimulation.

Research Team

Chet Moritz, PhD

Principal Investigator

University of Washington

Eligibility Criteria

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.

Ability to read, comprehend and speak English

It has been over 6 months since my stroke.

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

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

Treatment Details

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.

Participant Groups

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+