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

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT05591196
Status
Recruiting
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Conditions

  • Chronic Stroke
  • Stroke, Ischemic

Eligibility Criteria

Sex
ALL
Age
21 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Non-invasive Electrical Spinal Cord Stimulation — DEVICE
    Electrical stimulation of the spinal cord using surface electrodes
  • Activity Based Rehabilitation — OTHER
    Exercise therapy targeting paralyzed hand and arm

Study Details

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.

Key Dates

Start date
Oct 1, 2022
Status verified
Feb 2025
Primary completion
Jul 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
6 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • 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).

Primary Outcome Measure

Change from baseline - Fugl-Meyer assessment of the upper limb [ Time Frame: "Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 8 months." ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of WashingtonSeattleWashington98105
Fatma Inanici, MD, Ph.D.
[email protected]
2067872692
Fatma Inanici, MD, PhD (SUB_INVESTIGATOR)
Chet T Moritz, PhD (PRINCIPAL_INVESTIGATOR)

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