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Autonomic Effects of Spinal Cord Stimulation in Spinal Cord Injury

NCT05960448 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-10-01

No results posted yet for this study

Summary

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.

Conditions

  • Orthostatic Hypotension

Interventions

OTHER

Transcutaneous Spinal Cord Stimulation (TSCS)

This is electrical stimulation delivered to the spinal cord through the skin and tissue using a cathode electrode to deliver the stimulation and anode electrodes to ground the circuit.

OTHER

Sham Transcutaneous Spinal Cord Stimulation

This is designed to appear like transcutaneous spinal cord stimulation without actually delivering the stimulation.

Sponsors & Collaborators

  • James J. Peters Veterans Affairs Medical Center

    lead FED

Principal Investigators

  • Jill M Wecht, EdD · James J. Peters Veterans Affairs Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-30
Primary Completion
2026-07-30
Completion
2026-07-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05960448 on ClinicalTrials.gov