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Active, Not Recruiting

NCT Number: NCT05664646

Autonomic Effects of Stimulation in 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Spinal Cord Injury Autonomic Nervous System Diseases Behavior Cardiovascular Diseases Central Nervous System Diseases Hypotension Hypotension, Orthostatic Motor Activity Nervous System Diseases Orthostatic Intolerance Primary Dysautonomias Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

James J. Peters VA Medical Center, Bronx, NY

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcutaneous Spinal Cord Stimulation

Device

Non-invasive electrical stimulation of the spinal cord.

Other names: TSCS

Primary outcomes

  1. Study 1. Arm Cycle Ergometry Outcome - Peak Workload

    Time frame: through study completion, up to 2 years

    Difference between active TSCS and sham TSCS conditions, measured in watts.

  2. Study 1. Arm Cycle Ergometry Outcome - Total Exercise Time

    Time frame: through study completion, up to 2 years

    Difference between active TSCS and sham TSCS conditions, measured in minutes.

  3. Study 1. Arm Cycle Ergometry Outcome - Recovery Heart Rate

    Time frame: through study completion, up to 2 years

    Difference between active TSCS and sham TSCS conditions, measured at 1 minute, 2 minutes, and 5 minutes.

  4. Study 2. Thermoregulatory Outcome - Core Temperature

    Time frame: through study completion, up to 2 years

    Difference between active TSCS and sham TSCS conditions, measured in degrees Celsius.

  5. Study 2. Thermoregulatory Outcome - Thermal Comfort

    Time frame: through study completion, up to 2 years

    Difference between active TSCS and sham TSCS conditions, measured using a Likert scale.

  6. Study 2. Thermoregulatory Outcome - Thermal Sensation

    Time frame: through study completion, up to 2 years

    Difference between active TSCS and sham TSCS conditions, measured using a Likert scale.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Autonomic Effects of Transcutaneous Spinal Cord Stimulation in Veterans With SCI

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 27, 2022
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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