Spinal Cord Stimulation for Hand and Arm Recovery After Stroke

This study is looking at a new way to help people recover movement in their hand and arm after a stroke. It combines non-invasive electrical spinal cord stimulation (using surface electrodes on your skin) with activity-based rehabilitation (exercises for your hand and arm). The goal is to see if this combination can improve movement and strength in people who have had an ischemic stroke (a stroke caused by a blood clot) at least six months ago. Researchers will measure changes in arm and hand function, pinch and grip strength, and muscle stiffness over about 8 months. You may be able to join if you are 21-80 years old, have had an ischemic stroke, and have moderate to mild weakness in your upper limb.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 6 participants.
What's involved
Measurements will be taken at the start and then every two weeks throughout the study, which will last an average of 8 months.
Compensation
Not stated in the trial record.
Follow-up
Measurements will be taken for an average of 8 months.

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NCT05591196

Hand and Arm Motor Recovery Via Non-invasive Electrical Spinal Cord Stimulation After Stroke

Recruiting
NAAges 21–80InterventionalTreatment
University of Washington
~6 participants
Updated 2025-03-05 on ClinicalTrials.gov
What's tested:Non-invasive Electrical Spinal Cord StimulationActivity Based Rehabilitation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from baseline - Fugl-Meyer assessment of the upper limb
Measured over "Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 8 months."
+3 more outcomes measured
Stroke, Ischemic
Chronic Stroke
1 sites across 1 states
Washington1
  • Chet Moritz, PhD · PRINCIPAL_INVESTIGATOR · University of Washington

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Eligibility criteria

Inclusion

Radiologically documented single ischemic stroke resulted in hemiplegia/hemiparesis
At least six months post-stroke
Upper Extremity Fugl-Meyer Assessment score "moderate" or "moderate-mild" (29-53 inclusive out of 66) at the screening visit
Medically and neurologically stable, as determined by medical history and documented physical examination
For women of childbearing potential, a negative over-the-counter pregnancy test at study entry and willingness to practice adequate contraception during the study
Ability to attend sessions three times per week
Adequate social support to participate in all intervention and baseline, follow-up assessment sessions throughout eight months.
Ability to read, comprehend and speak English

Exclusion

Hemorrhagic stroke
History of multiple strokes
Active implanted stimulator (e.g., pacemaker, vagus nerve stimulator, cochlear implant, etc.) or baclofen pump
Aphasia or any other deficit in communication that interferes with reasonable study participation
Moderate to severe cognitive impairment
Presence of neglect (inability to perceive or awareness of, or loss of attention to the weaker half of the body)
Severe spasticity in the upper limb
Taking baclofen more than 30 mg/day
Change in baclofen dose within four weeks before enrollment
Receiving benzodiazepines, dantrolene, tizanidine, anticoagulant, or antiepileptic medication
Botulinum toxin injection to the upper limb muscles within six months before enrollment
Severe joint contractures in the affected hand and arm
History of spontaneous seizure that had occurred one month or longer after the stroke
  • Change from baseline - Fugl-Meyer assessment of the upper limb"Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 8 months."

    The clinician-administered a stroke-specific, performance-based impairment scale. It assesses movement function, sensation, joint range of motion, and pain. The score ranges from 0 to 66. Higher scores indicate better outcomes.

  • Change from baseline - Pinch and grip force"Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 8 months."

    Measurement of hand strengths using a dynamometry.

  • Change from baseline - Modified Ashworth Scale"Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 8 months."

    Clinician-administered test for resistance of a joint to passive movement. This scale grades muscle tone/spasticity. The score ranges from 0 to 4. Higher scores indicate worse outcomes.

  • Change from baseline - Wolf Motor Function Test"Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 8 months."

    Quantifies upper limb motor ability through timed and functional tasks. The score range is 0-75; higher scores denote better function.