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Autonomic Effects of Spinal Cord Stimulation in Spinal Cord Injury

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Enrollment closed, study ongoing
    • Site details revised
    v4
  2. Re-verified, no change to tracked fieldsv3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Secondary endpoints: 6 to 2
    • Study description expanded, about 11 words
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this interventional crossover study is to determine the effects of transcutaneous spinal cord stimulation (TSCS) on the ability to perform moderate exercise and regulate core body temperature in the chronic spinal cord injury community. The main questions it aims to answer are: * What are the effects of active TSCS targeted for BP control on exercise endurance time and HR recovery during submaximal arm cycle ergometry (ACE) as compared to sham TSCS in participants with chronic, cervical SCI? * What are the effects of active TSCS on Tcore responses to cool ambient exposure and on subjective reporting of thermal comfort and thermal sensitivity as compared to sham TSCS. Participants will receive sham and active stimulation while using an arm bicycle or while in a cold room. Participants are free to participate in either the exercise phase, the cold room phase, or both phases of this study. Please note that there no expected long term benefits of this study.
Trial Details
NCT Number NCT05960448
Lead Sponsor James J. Peters Veterans Affairs Medical Center
Conditions
(from sponsor)		 Orthostatic Hypotension
Related terms Hypotension, Orthostatic, Motor Activity
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov