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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
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

HARNESS Trial 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.Check my eligibility
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.See study design
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.

HARNESS Trial 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.

HARNESS Trial 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."
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Upper Extremity
Change from baseline - Modified Ashworth Scale
Change from baseline - Pinch and grip force
+1 more
Secondary outcome measures
Change from baseline - Action Research Arm Test
Change from baseline - Box and Blocks Test
Change from baseline - H-reflex test
+6 more

HARNESS 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).

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor
1,740 Previous Clinical Trials
1,847,932 Total Patients Enrolled
15 Trials studying Stroke
8,596 Patients Enrolled for Stroke
Chet Moritz, PhDPrincipal InvestigatorUniversity of Washington
1 Previous Clinical Trials
65 Total Patients Enrolled

Media Library

Activity Based Rehabilitation Clinical Trial Eligibility Overview. Trial Name: NCT05591196 — N/A
Stroke Research Study Groups: Activity Based Rehabilitation, Non-invasive Electrical Spinal Cord Stimulation + Activity Based Rehabilitation
Stroke Clinical Trial 2023: Activity Based Rehabilitation Highlights & Side Effects. Trial Name: NCT05591196 — N/A
Activity Based Rehabilitation 2023 Treatment Timeline for Medical Study. Trial Name: NCT05591196 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment for this scientific experiment still underway?

"Affirmative. Data hosted on clinicaltrials.gov indicates that this research venture, which was first circulated on October 1st 2022, is actively seeking volunteers. Approximately 6 participants are needed from a single medical site."

Answered by AI

Does the eligibility for this trial extend beyond those aged 65 and below?

"The protocol of this trial requires that candidates are at least 21 years old and not older than 80."

Answered by AI

How many participants are included in the current research?

"Affirmative. Data hosted on clinicaltrials.gov points to the fact that this medical study, which was first posted on October 1st 2022, is currently recruiting patients. Approximately 6 people are sought from one site for participation in the trial."

Answered by AI

Who qualifies to be involved in this medical trial?

"This trial is recruiting 6 participants with chronic stroke ranging between 21 and 80 years of age. To be eligible, they must possess the capacity to attend three sessions per week; provide adequate social support throughout 8 months; comprehend English language through reading, speaking or listening; have had a single radiologically documented ischemic stroke resulting in hemiplegia/hemiparesis at least six months prior; demonstrate moderate-mild upper extremity Fugl-Meyer Assessment score (29-53 out of 66); remain medically and neurologically stable as determined by medical history combined with physical examination findings. Lastly, women who may become pregnant"

Answered by AI

What are the intended outcomes of this research?

"The primary metric evaluated during this clinical trial, spanning approximately 8 months, is the Fugl-Meyer assessment of upper limb dexterity. Supporting secondary outcomes include Box and Blocks Test scores (measuring gross manual coordination), Stroke Impact Scale results (evaluating disability/health quality after stroke) and Spinally evoked motor potentials test values (electrophysiological tests)."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Hand and Arm Motor Recovery Via Non-invasive Electrical Spinal Cord Stimulation After Stroke
Chet Moritz 2022. "Hand and Arm Motor Recovery Via Non-invasive Electrical Spinal Cord Stimulation After Stroke". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05591196.
~1 spots leftby Sep 2024
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