Autonomic Effects of Stimulation in SCI

July 1, 2025 updated by: VA Office of Research and Development

Autonomic Effects of Transcutaneous Spinal Cord Stimulation in Veterans With SCI

This study aims to determine the effects of transcutaneous spinal cord stimulation to increase blood pressure and use that device to increase power output and heart rate recovery during arm cycle ergometry. In addition, the investigators will see if the stimulation helps regulate body temperature when in a cool environment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study aims to determine the effects of transcutaneous spinal cord stimulation to increase blood pressure and use that device to increase exercise power output and heart rate recovery during arm cycle ergometry. In addition, the investigators will see if the stimulation helps regulate body temperature when in a cool environment. Study 1 (arm cycle ergometry) will consist of 2 visits that will be between 2-3 hours in duration, separated by no less than 3 days, and will consist of putting the electrode at the optimal spot on the spine and completing a submaximal arm ergometry exercise and the other visit will be a sham visit. Study 2 (cool environment) will consist of 2 visits that will be between 3-4 hours in duration, separated by no less than 3 days, and will consist of assessing core temperature when in a cool environment with the stimulator on and off.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jill Wecht, EdD
  • Phone Number: 3122 (718) 584-9000
  • Email: jm.wecht@va.gov

Study Contact Backup

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10468-3904
        • Recruiting
        • James J. Peters VA Medical Center, Bronx, NY
        • Principal Investigator:
          • Jill Wecht, EdD
        • Contact:
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

35 years to 50 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • injury more than 1 year ago, non-ambulatory
  • level of lesion C3-T6, AIS A, B, or C
  • stable prescription medication regimen for at least 30 days
  • must be able to commit to study requirements of 7 visits within a 60-day period

Exclusion Criteria:

  • extensive history of seizures
  • ventilator dependence or patent tracheostomy site
  • history of neurologic disorder other than SCI
  • history of moderate or severe head trauma
  • contraindications to spine stimulation
  • significant cardiovascular disease
  • active psychological disorder
  • recent history (within 3 months) of substance abuse
  • open skin lesions over spine at levels targeted for stimulation (L1/L2) and pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Without stimulation
For study 1, exercise power output and heart rate recovery will be measured after arm ergometry without stimulation. For study 2, body core temperature and thermal comfort will be reported without stimulation.
Other: Arm Ergometry
Study 1 will use the arm ergometry as a form of exercise.
Other Names:
  • Arm cycling
Other: Cool Environment
Study 2 will be completed in a cool environment setting.
Active Comparator: With stimulation
For study 1, exercise power output and heart rate recovery will be measured after arm ergometry with stimulation. For study 2, body core temperature and thermal comfort will be reported with stimulation.
Device: DS8R
transcutaneous stimulation of the spinal cord.
Other Names:
  • Transcutaneous Stimulation
Other: Arm Ergometry
Study 1 will use the arm ergometry as a form of exercise.
Other Names:
  • Arm cycling
Other: Cool Environment
Study 2 will be completed in a cool environment setting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart Rate Recovery Time
Time Frame: through study completion, up to 2 years
Determine if TSCS shortens the amount of time for HR recovery (return to baseline) compared to no stimulation.
through study completion, up to 2 years
Body Core Temperature
Time Frame: through study completion, up to 2 years
Determine if TSCS helps maintain body core temperature in a cool environment compared to no stimulation.
through study completion, up to 2 years
Power Output
Time Frame: through study completion, up to 2 years
Determine if TSCS increases power output (watts) compared to no stimulation.
through study completion, up to 2 years
Total Distance Achieved
Time Frame: through study completion, up to 2 years
Determine if TSCS increases total distance (miles) achieved during arm ergometry compared to no stimulation.
through study completion, up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exercise Endurance Time
Time Frame: through study completion, up to 2 years
Determine if TSCS increases exercise endurance time compared to no stimulation.
through study completion, up to 2 years
Subjective Reporting on Thermal Comfort and Thermal Sensation
Time Frame: through study completion, up to 2 years
To determine if TSCS helps improve subjective reporting on thermal comfort and thermal sensation compared to no stimulation.
through study completion, up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Jill Wecht, EdD, 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 Major Dates

Study Start (Actual)

July 24, 2023

Primary Completion (Estimated)

July 30, 2026

Study Completion (Estimated)

July 30, 2026

Study Registration Dates

First Submitted

December 15, 2022

First Submitted That Met QC Criteria

December 15, 2022

First Posted (Actual)

December 27, 2022

Study Record Updates

Last Update Posted (Actual)

July 4, 2025

Last Update Submitted That Met QC Criteria

July 1, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B4373-P
  • 1I21RX004373-01A1 (U.S. NIH Grant/Contract: RR&D)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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