Autonomic Effects of Stimulation in SCI

NCT05664646 | 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 (4)

• Power Output

  Determine if TSCS increases power output (watts) compared to no stimulation.

  through study completion, up to 2 years

• Heart Rate Recovery Time

  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

• Total Distance Achieved

  Determine if TSCS increases total distance (miles) achieved during arm ergometry compared to no stimulation.

  through study completion, up to 2 years

• Body Core Temperature

  Determine if TSCS helps maintain body core temperature in a cool environment compared to no stimulation.

  through study completion, up to 2 years

Secondary Outcomes (2)

• Subjective Reporting on Thermal Comfort and Thermal Sensation

  through study completion, up to 2 years

• Exercise Endurance Time

  through study completion, up to 2 years

Study Arms (2)

Without stimulation

SHAM COMPARATOR

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; Other: Cool Environment

With stimulation

ACTIVE COMPARATOR

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; Other: Arm Ergometry; Other: Cool Environment

Interventions

DS8R DEVICE

transcutaneous stimulation of the spinal cord.

Also known as: Transcutaneous Stimulation

With stimulation

Arm Ergometry OTHER

Study 1 will use the arm ergometry as a form of exercise.

Also known as: Arm cycling

With stimulation; Without stimulation

Cool Environment OTHER

Study 2 will be completed in a cool environment setting.

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

RECRUITING

MeSH Terms

Conditions

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

Interventions

Transcutaneous Electric Nerve Stimulation; Exercise Test

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

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• Jill Wecht, EdD

  James J. Peters Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jill Wecht, EdD

CONTACT

(718) 584-9000; jm.wecht@va.gov

Matthew T Maher, MS

CONTACT

(718) 584-9000; matthew.maher@va.gov

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 (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)