Transcutaneous Spinal Stimulation and Exercise for Locomotion

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT03509558
Status
Recruiting
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Conditions

  • Spinal Cord Injuries

Eligibility Criteria

Sex
ALL
Age
21 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Transcutaneous spinal stimulation — DEVICE
    Non-invasive electrical stimulation of spinal cord over the skin combined with physical therapy to improve walking and standing functions
  • Physical Therapy — OTHER
    physical therapy to improve walking and standing functions

Study Details

Growing evidence indicates that electrical spinal cord stimulation improves motor functions both immediately and over the long term via modulating the excitability of spinal circuitry in patients with spinal cord injury. Recently, a novel, non-invasive, well-tolerated, and painless lumbosacral transcutaneous electrical stimulation strategy was demonstrated to be effective in improving lower limb motor function in participants with spinal cord injury. Our current project, cervical transcutaneous electrical stimulation and intensive exercise for arms and hands are also revealing a significant improvement in upper extremity function. Additionally, the subject and caregiver noted that stair climbing ability has been substantially enhanced starting from the first week of cervical stimulation treatment and continues to date. This study is a prospective efficacy trial of combined transcutaneous cervical and lumbosacral electrical stimulation with physical therapy for improving locomotion in people with anatomically incomplete tetraplegia and paraplegia. This experiment design consists of testing walking function with and without transcutaneous spinal cord stimulation. A two to four-phase intervention program will include physical therapy and spinal cord stimulation with physical therapy. The length of any intervention phase, and number of measurements performed during that phase, will be determined by multiple factors, including participants' health condition, availability, and response to intervention. Between each intervention, washout periods of up to one month may be used to determine any after-effects of the interventions. The intervention arms will be repeated if the functional improvement does not reach a plateau during the first two months of intervention. Physical therapy will include functional training (e.g., walking training) and strength training. Each spinal cord stimulation with physical therapy intervention block can use transcutaneous lumbosacral stimulation or cervical and lumbosacral stimulation. Both immediate and lasting improvements in lower extremity function and autonomic function via transcutaneous spinal cord stimulation and intensive physical therapy may be evaluated.

Key Dates

Start date
Feb 28, 2018
Status verified
Mar 2025
Primary completion
Sep 30, 2025
Completion
Sep 30, 2026

Study Design

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

Arms

  • Active Comparator: Transcutaneous spinal stimulation & Physical therapy
    Transcutaneous electrical stimulation combined with physical therapy that targets rehabilitation of walking and standing functions
  • Active Comparator: Physical therapy only
    Physical therapy that targets rehabilitation of walking and standing functions

Primary Outcome Measure

Six-Minute Walk Test [ Time Frame: 1-11 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of WashingtonSeattleWashington98195
Soshi Samejima
[email protected]
Chet Moritz
[email protected]
Chet Moritz, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Washington· Seattle, WA

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