RECRUITING

Autonomic Effects of Spinal Cord Stimulation in Spinal Cord Injury

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-07-30
Study Completion:2026-07-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05960448

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * You are above the age of 18 years old
  2. * You have an SCI between C3-T6
  3. * You have been injured longer than 1 year
  4. * You participated in a prior experiment "Targeted Transcutaneous Spinal Cord Stimulation to Restore Autonomic Cardiovascular Health in Individuals with Spinal Cord Injury"
  5. * You have an American Spinal Injury Association injury classification scale (AIS) A, B, C
  6. * Your prescription medications have not changed for at least 30 days
  1. * You have a history of seizures
  2. * You have an acute illness or infection
  3. * You have diabetes
  4. * You have untreated thyroid disease
  5. * You have a neurological condition other than SCI (Alzheimer's disease, dementia, stroke, multiple sclerosis, Parkinson's disease, etc.)
  6. * You have a history of heart or vascular disease (coronary artery disease, congestive heart failure, peripheral artery disease,)
  7. * You have a history of moderate or severe head trauma (TBI) or diagnosed with cognitive impairment
  8. * You have a present or history of a psychological disorder
  9. * You have contraindications to electricity over your spine
  10. * You are dependent on a ventilator to breathe or have an open tracheostomy site
  11. * You have a recent history of substance abuse (within the past 3 months)
  12. * You have open wounds over the spine at the level targeted for stimulation
  13. * You are pregnant

Contacts and Locations

Study Contact

Matthew T Maher, MS
CONTACT
(718) 584-9000
Matthew.Maher@va.gov
Fiona E Fox, BS
CONTACT
(718) 584-9000
fefox16@gmail.com

Principal Investigator

Jill M Wecht, EdD
PRINCIPAL_INVESTIGATOR
James J. Peters Veterans Affairs Medical Center

Study Locations (Sites)

James J Peters VAMC
Bronx, New York, 10468
United States

Collaborators and Investigators

Sponsor: James J. Peters Veterans Affairs Medical Center

  • Jill M Wecht, EdD, PRINCIPAL_INVESTIGATOR, James J. Peters Veterans Affairs Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-30
Study Completion Date2026-07-30

Study Record Updates

Study Start Date2023-07-30
Study Completion Date2026-07-30

Terms related to this study

Keywords Provided by Researchers

  • neuromodulation
  • stimulation
  • exercise
  • hand bike
  • thermoregulation
  • cold room

Additional Relevant MeSH Terms

  • Orthostatic Hypotension