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Clinical Trial

Transcutaneous Spinal Stimulation and Exercise for Locomotion

NCT: NCT03509558 · RECRUITING

NCT IDNCT03509558
StatusRECRUITING
Start Date2018-02-28
Completion2028-09-30
SponsorUniversity of Washington (OTHER)
First posted
Last updated

Brief Summary

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.

Frequently Asked Questions

What is Transcutaneous Spinal Stimulation and Exercise for Locomotion?

Transcutaneous Spinal Stimulation and Exercise for Locomotion is a clinical trial registered under NCT03509558. Current status: RECRUITING.

What is the status of NCT03509558?

The current status of NCT03509558 (Transcutaneous Spinal Stimulation and Exercise for Locomotion) is: RECRUITING.

When did Transcutaneous Spinal Stimulation and Exercise for Locomotion start?

Transcutaneous Spinal Stimulation and Exercise for Locomotion started on 2018-02-28.

Official Source

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Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.