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

Launched by UNIVERSITY OF WASHINGTON · Oct 18, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating a new way to help improve hand and arm movement for people who have had a stroke. Many stroke survivors experience difficulties with using their hands and arms, which can greatly affect their daily lives. Researchers are exploring whether using gentle electrical stimulation on the spinal cord, combined with special rehabilitation exercises, can help these individuals regain better function in their upper limbs. The goal is to see if this approach can lead to lasting improvements even after the treatment has ended.

To be eligible for this study, participants should be between 18 and 80 years old and must have had a single ischemic stroke (the most common type) at least six months prior, resulting in some weakness or paralysis on one side of their body. They should also be stable health-wise and able to attend therapy sessions three times a week. Throughout the study, participants will receive non-invasive spinal stimulation and practice using their hands and arms in various tasks. This trial is open to both men and women, and those interested should have good support to help them participate fully. If you're looking for a new way to help recover hand and arm function after a stroke, this trial could be an exciting opportunity!

Gender

ALL

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