Autonomic Effects of Transcutaneous Spinal Cord Stimulation in Veterans With Spinal Cord Injury (SCI)

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• You are above the age of 18 years old

• You have an SCI between C3-T6

• You have been injured longer than 1 year

• You participated in a prior experiment Targeted Transcutaneous Spinal Cord Stimulation to Restore Autonomic Cardiovascular Health in Individuals with Spinal Cord Injury

• You have an American Spinal Injury Association injury classification scale (AIS) A, B, C

• Your prescription medications have not changed for at least 30 days

Locations
United States
New York
James J Peters VAMC
RECRUITING
The Bronx
Contact Information
Primary
Matthew T Maher, MS
Matthew.Maher@va.gov
(718) 584-9000
Backup
Fiona E Fox, BS
fefox16@gmail.com
(718) 584-9000
Time Frame
Start Date: 2023-07-30
Estimated Completion Date: 2026-07-30
Participants
Target number of participants: 20
Treatments
Experimental: Transcutaneous Spinal Cord Stimulation
The transcutaneous spinal cord stimulation used in this experiment is specific to each participant as determined in a previous study. Possible parameters include biphasic or monophasic, Russian or Nonrussian, a variety of pulse widths, and location of stimulation (T7-8, T9-10,- T11-12, L1-2). The amplitude of the stimulation also depends on the results of the mapping study. This stimulation will be delivered 30 minutes at a time.
Sham_comparator: Sham Transcutaneous Spinal Cord Stimulation
The sham stimulation will follow the above parameters but will only be delivered for a minute rather than the full 30 minutes.
Sponsors
Leads: James J. Peters Veterans Affairs Medical Center

This content was sourced from clinicaltrials.gov