Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05960448 |
Other study ID # |
1727500 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
July 30, 2023 |
Est. completion date |
July 30, 2026 |
Study information
Verified date |
August 2023 |
Source |
James J. Peters Veterans Affairs Medical Center |
Contact |
Matthew T Maher, MS |
Phone |
(718) 584-9000 |
Email |
Matthew.Maher[@]va.gov |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
Description:
The purpose of the first part of this research study is to determine the effects of active
transcutaneous spinal cord stimulation (TSCS) targeted for blood pressure (BP) control on
exercise endurance time and heart rate (HR) recovery time during an arm cycle test. The
results will help guide experimental studies aimed at improving exercise, rehabilitation,
health, and longevity in the SCI population. If the participant chooses to participate in
part one of this study, the participant will be asked to visit the laboratory for 2 visits
that take about 3-4 hours each.
The purpose of part two of this study is to compare the effects of electricity being
delivered through surface electrodes (sticky pads on the participants skin), called active
transcutaneous spinal cord stimulation (TSCS), compared to sham TSCS (sticky pads with
electricity initially turned on but then turned off) on the participants ability to 1) keep
the participants body temperature stable and 2) feel comfortable, while in a cool environment
(cool room at 64° F) for 90 minutes. The investigators will assess the participant thermal
sensation by asking the participant if overall they feel cold, cool, neutral, warm, or hot
and their comfort level by asking the participant to grade their thermal comfort (how
comfortable or how uncomfortable they feel) when the participant is seated in a thermoneutral
room (80° F) and again in the cool room with active TSCS compared to the cool room with sham
TSCS. The results will help guide experimental studies aimed at improving health and
longevity in the population with SCI. If the participant chooses to participate in this
study, there will be 2 study visits that last about 3-4 hours each.