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HARNESSNCT05591196

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

StatusRecruiting
PhaseNot applicable
Primary completion (estimated)

At risk: Primary completion moved at least 1 year 5 months later.

See at-risk trials from University of Washington

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Record History

All 4 versions: 3 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion dates pushed to Dec 31, 2027
    • Eligibility criteria expanded, about 21 words
    • Secondary endpoints: details revised at 9 of 9 entries
  2. Primary completion date: Sep 30, 2024 to Jul 30, 2026
    • Study completion date: Dec 31, 2024 to Dec 31, 2026
    • Site contact updated
    v3
  3. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Change from baseline - Fugl-Meyer assessment of the upper limb
Timeframe: "Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 8 months."
Change from baseline - Pinch and grip force
Timeframe: "Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 8 months."
Change from baseline - Modified Ashworth Scale
Timeframe: "Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 8 months."
Change from baseline - Wolf Motor Function Test
Timeframe: "Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 8 months."

Secondary (9)

Change from baseline - Action Research Arm Test
Change from baseline - Box and Blocks Test
Change from baseline - Revised Nottingham Sensory Assessment
Change from baseline - Stroke Impact Scale
Change from baseline - Short Form-36
Show 4 moreShow less
Change from baseline - Patients Global Impression of Change
Change from baseline - H-reflex test
Change from baseline - Somatosensory evoked potentials test
Change from baseline - Spinally evoked motor potentials test

Arms and interventions

Activity Based RehabilitationActive comparator

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).

Non-invasive Electrical Spinal Cord Stimulation + Activity Based RehabilitationExperimental

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).

Devices: Non-invasive Electrical Spinal Cord Stimulation

Other: Activity Based Rehabilitation

Sites

1 site in 1 country

  • University of WashingtonSeattle, Washington, United States