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NCT05960448

Autonomic Effects of Spinal Cord Stimulation in Spinal Cord Injury

Recruiting now NA Last updated 1 October 2024
What this trial tests

NA trial testing Transcutaneous Spinal Cord Stimulation (TSCS) in Orthostatic Hypotension in 20 participants. Currently enrolling.

Timeline
30 July 2023
Primary endpoint
30 July 2026
30 July 2026

Quick facts

Lead sponsorJames J. Peters Veterans Affairs Medical Center
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingsingle
Primary purposetreatment
Enrollment20
Start date30 July 2023
Primary completion30 July 2026
Estimated completion30 July 2026
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

James J. Peters Veterans Affairs Medical Center

Who can join

18 and older, any sex, with Orthostatic Hypotension. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Strategies to Augment the Cardiovascular System and Acutely Enhance Exercise Performance in Individuals with Spinal Cord Injury: A Systematic Scoping Review.
    Hodgkiss DD, Balthazaar SJT, Gee CM, Chiou SY, et al · · 2025 · PMID 41196455 · DOI 10.1186/s40798-025-00909-7

Verify or expand the search:

Other recruiting trials for Orthostatic Hypotension

Currently open trials in the same condition.

Other James J. Peters Veterans Affairs Medical Center trials

Trials by the same sponsor.

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing