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

Status: Recruiting
Location: See location...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
United States
Washington
University of Washington
RECRUITING
Seattle
Contact Information
Primary
Fatma Inanici
finanici@uw.edu
206-787-2692
Time Frame
Start Date: 2022-10-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 6
Treatments
Active_comparator: Activity Based Rehabilitation
Activity Based Rehabilitation is comprised of intensive, progressive, functional task practice. The protocol consists of repetitive activities of gross upper limb movement, isolated finger movements, bimanual task performance, simple and complex pinch, and grip performance. Several activities with various difficulty levels are designated for each category, and the participant will perform 1-2 activities within each category in each rehabilitation session. Rehabilitation sessions will be three times per week, 90 minutes per session for six weeks (total of 18 sessions).
Experimental: Non-invasive Electrical Spinal Cord Stimulation + Activity Based Rehabilitation
Non-invasive electrical spinal cord stimulation will be performed using surface electrodes placed over the skin of the neck. Biphasic rectangular pulses of 1 millisecond per phase duration will be delivered with a 10 kiloHertz overlapping frequency and between 20-120 Hertzz burst frequency. Non-invasive electrical spinal cord stimulation will be paired with Activity Based Rehabilitation sessions. Stimulation plus rehabilitation sessions will be three times per week, 90 minutes per session for six weeks (total of 18 sessions).
Related Therapeutic Areas
Sponsors
Leads: University of Washington

This content was sourced from clinicaltrials.gov