NCT05591196 Hand and Arm Motor Recovery Via Non-invasive Electrical Spinal Cord Stimulation After Stroke
| NCT ID | NCT05591196 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Washington |
| Condition | Stroke, Ischemic |
| Study Type | INTERVENTIONAL |
| Enrollment | 6 participants |
| Start Date | 2022-10-01 |
| Primary Completion | 2026-07-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 6 participants in total. It began in 2022-10-01 with a primary completion date of 2026-07-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Chet Moritz, PhD
PRINCIPAL INVESTIGATOR
University of Washington
Frequently Asked Questions
Who can join the NCT05591196 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 80 Years, studying Stroke, Ischemic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05591196 currently recruiting?
Yes, NCT05591196 is actively recruiting participants. Contact the research team at finanici@uw.edu for enrollment information.
Where is the NCT05591196 trial being conducted?
This trial is being conducted at Seattle, United States.
Who is sponsoring the NCT05591196 clinical trial?
NCT05591196 is sponsored by University of Washington. The principal investigator is Chet Moritz, PhD at University of Washington. The trial plans to enroll 6 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.