Improving hand and arm recovery after stroke using electrical stimulation
Hand and Arm Motor Recovery Via Non-invasive Electrical Spinal Cord Stimulation After Stroke
NA · University of Washington · NCT05591196
This study is testing if using electrical stimulation along with rehabilitation can help people who have had a stroke regain movement in their hands and arms.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 6 (estimated) |
| Ages | 21 Years to 80 Years |
| Sex | All |
| Sponsor | University of Washington (other) |
| Locations | 1 site (Seattle, Washington) |
| Trial ID | NCT05591196 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of non-invasive electrical spinal cord stimulation combined with activity-based rehabilitation to enhance hand and arm function in patients who have experienced a chronic ischemic stroke. The researchers aim to activate spinal networks that have lost control due to the stroke, potentially leading to improved voluntary movement in paralyzed muscles. Participants will undergo treatment sessions three times a week over an eight-month period, with assessments to measure functional recovery. The study seeks to address the inadequacies of current rehabilitation methods for upper limb recovery post-stroke.
Who should consider this trial
Good fit: Ideal candidates are individuals who have experienced a single ischemic stroke resulting in hemiplegia or hemiparesis, at least six months post-stroke, and have moderate to mild upper extremity function.
Not a fit: Patients with hemorrhagic strokes, multiple strokes, or those with active implanted stimulators will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve hand and arm function in stroke survivors, enhancing their quality of life.
How similar studies have performed: Other studies have shown promise with electrical spinal cord stimulation in similar neurological conditions, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Seattle, Washington
- University of Washington — Seattle, Washington, United States (RECRUITING)
Study contacts
- Principal investigator: Chet Moritz, PhD — University of Washington
- Study coordinator: Fatma Inanici
- Email: finanici@uw.edu
- Phone: 206-787-2692
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Stroke, Ischemic, Chronic Stroke, Chronic ischemic stroke, Transcutaneous spinal cord stimulation, Activity based rehabilitation