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NCT05960448 · ClinicalTrials.gov registry record · NA
Autonomic Effects of Spinal Cord Stimulation in Spinal Cord Injury
A NA study of Orthostatic Hypotension, sponsored by James J. Peters Veterans Affairs Medical Center.
- Recruiting
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT05960448 is a NA study of Orthostatic Hypotension that is actively recruiting participants, run by James J. Peters Veterans Affairs Medical Center. The registered enrollment target is 20 participants, below the 51-participant average among 16 other Orthostatic Hypotension trials with a reported enrollment target (61% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05960448, a NA study of Orthostatic Hypotension, is actively recruiting participants, sponsored by James J. Peters Veterans Affairs Medical Center.
- RECRUITING
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
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 Studied
Interventions
- OTHER Transcutaneous Spinal Cord Stimulation (TSCS)
- OTHER Sham Transcutaneous Spinal Cord Stimulation
Study Locations (1)
New York
- James J Peters VAMC - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2023-07-30 |
| Est. Completion | 2026-07-30 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05960448
The ClinicalTrials.gov registry entry for NCT05960448 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 51-participant average among 16 other Orthostatic Hypotension trials with a reported enrollment target (61% lower). The listed sponsor is James J. Peters Veterans Affairs Medical Center, which has 39 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Orthostatic Hypotension appearing as the primary indexed condition, and to 2 interventions - of which Transcutaneous Spinal Cord Stimulation (TSCS) is the first listed.
NCT05960448 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT05960448 about?
NCT05960448 is a clinical study titled "Autonomic Effects of Spinal Cord Stimulation in Spinal Cord Injury". 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 a...
What is the current status of trial NCT05960448?
This trial is currently recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2023-07-30. Estimated completion is 2026-07-30.
What conditions does trial NCT05960448 study?
This clinical trial studies the following conditions: Orthostatic Hypotension.
What interventions are being tested in trial NCT05960448?
The interventions under investigation include: Transcutaneous Spinal Cord Stimulation (TSCS) (OTHER), Sham Transcutaneous Spinal Cord Stimulation (OTHER).
Who is sponsoring clinical trial NCT05960448?
This trial is sponsored by James J. Peters Veterans Affairs Medical Center, which has 39 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05960448 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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