Autonomic Effects of Stimulation in SCI

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: Active, not recruiting
• Conditions: Spinal Cord Injury
• Intervention / Treatment: Device: Transcutaneous Spinal Cord Stimulation

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 (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • The Bronx, New York, United States, 10468-3904
      • James J. Peters VA Medical Center, Bronx, NY

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Transcutaneous Spinal Cord Stimulation; Non-invasive electrical stimulation of the spinal cord.; Other Names: TSCS
Experimental: 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: Transcutaneous Spinal Cord Stimulation; Non-invasive electrical stimulation of the spinal cord.; Other Names: TSCS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study 1. Arm Cycle Ergometry Outcome - Peak Workload	Difference between active TSCS and sham TSCS conditions, measured in watts.	through study completion, up to 2 years
Study 1. Arm Cycle Ergometry Outcome - Total Exercise Time	Difference between active TSCS and sham TSCS conditions, measured in minutes.	through study completion, up to 2 years
Study 1. Arm Cycle Ergometry Outcome - Recovery Heart Rate	Difference between active TSCS and sham TSCS conditions, measured at 1 minute, 2 minutes, and 5 minutes.	through study completion, up to 2 years
Study 2. Thermoregulatory Outcome - Core Temperature	Difference between active TSCS and sham TSCS conditions, measured in degrees Celsius.	through study completion, up to 2 years
Study 2. Thermoregulatory Outcome - Thermal Comfort	Difference between active TSCS and sham TSCS conditions, measured using a Likert scale.	through study completion, up to 2 years
Study 2. Thermoregulatory Outcome - Thermal Sensation	Difference between active TSCS and sham TSCS conditions, measured using a Likert scale.	through study completion, up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exercise Endurance Time	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	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

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Jill Wecht, EdD, James J. Peters Veterans Affairs Medical Center

Study record dates

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 2, 2026
• Last Update Submitted That Met QC Criteria: June 30, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Exercise; Hypotension; Blood Pressure; Orthostatic Hypotension; Body Core Temperature
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Primary Dysautonomias; Autonomic Nervous System Diseases; Orthostatic Intolerance; Behavior; Hypotension; Spinal Cord Injuries; Hypotension, Orthostatic; Motor Activity
• 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