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Spinal Cord Stimulation + Rehabilitation for Stroke (HARNESS Trial)

N/A

Recruiting

Led By Chet Moritz, PhD

Research Sponsored by University of Washington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Upper Extremity Fugl-Meyer Assessment score "moderate" or "moderate-mild" (29-53 inclusive out of 66) at the screening visit

Radiologically documented single ischemic stroke resulted in hemiplegia/hemiparesis

Must not have

Taking baclofen more than 30 mg/day

Severe joint contractures in the affected hand and arm

Timeline

Screening 3 weeks

Treatment Varies

Follow Up "measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 8 months."

Awards & highlights

No Placebo-Only Group

Summary

This trial seeks to find if non-invasive spinal stimulation combined with activity-based rehabilitation can improve hand and arm movement in people with a stroke.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort at the electrode site, muscle fatigue from rehabilitation exercises, and possible skin irritation from the electrodes. The exact side effects will vary depending on individual tolerance to electrical stimulation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My arm and hand movement ability is moderately impaired.

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I had a stroke that caused weakness or paralysis on one side of my body.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I take more than 30 mg of baclofen daily.

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I have severe stiffness in my hand and arm joints.

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I have significant memory or thinking problems.

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I have had a bleeding stroke.

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I have had more than one stroke.

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I have severe muscle stiffness in my arm.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ "measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 8 months."

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~"measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 8 months."

This trial's timeline: 3 weeks for screening, Varies for treatment, and "measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 8 months." for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Upper Extremity

Change from baseline - Modified Ashworth Scale

Change from baseline - Pinch and grip force

+1 more

Secondary study objectives

Change from baseline - Action Research Arm Test

Change from baseline - Box and Blocks Test

Change from baseline - H-reflex test

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Non-invasive Electrical Spinal Cord Stimulation + Activity Based RehabilitationExperimental Treatment2 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 RehabilitationActive Control1 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).

0 / 8Eligibility criteria met