RecruitingNot ApplicableNCT05591196

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

Sponsor

University of Washington

Enrollment

6 participants

Start Date

Oct 1, 2022

Study Type

INTERVENTIONAL

Conditions

Stroke, Ischemic

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

Min Age: 21 YearsMax Age: 80 Years

Inclusion Criteria8

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 Criteria13

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