Ignite Creation Date:
2024-05-06 @ 7:17 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05960448
Status:
RECRUITING
Last Update Posted:
2023-08-15
First Post:
2023-07-17
Brief Title:
Autonomic Effects of Spinal Cord Stimulation in Spinal Cord Injury
Sponsor:
James J Peters Veterans Affairs Medical Center
Organization:
James J Peters Veterans Affairs Medical Center
Study Overview
Official Title:
Autonomic Effects of Transcutaneous Spinal Cord Stimulation in Veterans With Spinal Cord Injury SCI
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None