Autonomic Effects of Stimulation in SCI

NCT05664646 | Active Not Recruiting FDA Device

• 2 other identifiers: B4373-P1I21RX004373-01A1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spinal Cord Injury

Keywords

Orthostatic Hypotension; Exercise; Hypotension; Body Core Temperature; Blood Pressure

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Without stimulation

EXPERIMENTAL

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

With stimulation

EXPERIMENTAL

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

Interventions

Transcutaneous Spinal Cord Stimulation DEVICE

Non-invasive electrical stimulation of the spinal cord.

Also known as: TSCS

With stimulation; Without stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

James J. Peters VA Medical Center, Bronx, NY

The Bronx, New York, 10468-3904, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Hypotension, Orthostatic; Motor Activity; Hypotension

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior

Study Officials

• Jill Wecht, EdD

  James J. Peters Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: During both Study 1 and Study 2, the participants will be blinded to the order of completing the study with and without stimulation.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: During the study 1 visits, the participants will complete an arm ergometry exercise with the optimal stimulation parameters and without (sham). During study 2 visits, the participants' body core temperature will be measured about being exposed to a cool environment with stimulation and without (sham).

Study Record Dates

• First Submitted: December 15, 2022
• First Posted: December 27, 2022
• Study Start: July 24, 2023
• Primary Completion: July 30, 2026
• Study Completion: July 30, 2026
• Last Updated: July 2, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)