Transcutaneous Spinal Cord Stimulation for Spinal Cord Injury

This study is looking at how Transcutaneous Spinal Cord Stimulation (TSCS) affects people with chronic spinal cord injury (SCI). TSCS uses electrical stimulation delivered through the skin to the spinal cord. Researchers want to see if TSCS can improve your ability to exercise and help your body regulate its temperature. You would participate in activities like using an arm bicycle or being in a cool room while receiving either active TSCS or a sham (inactive) TSCS. The study aims to understand if TSCS can help with exercise endurance, heart rate recovery, and maintaining a stable body temperature. To join, you need to be over 18, have an SCI between C3-T6 for over a year, and have participated in a previous related study. This study is currently unclear on its recruitment status and plans to enroll 20 participants.

Study design
This is an interventional crossover study, meaning participants will receive both the active Transcutaneous Spinal Cord Stimulation (TSCS) and a sham (inactive) TSCS at different times. It plans to enroll 20 participants.
What's involved
You would visit the laboratory for two visits, each lasting about 3-4 hours. During these visits, you would receive active or sham stimulation while using an arm bicycle or being in a cool room.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints for this study are measured during procedures, specifically at 30, 60, and 90 minutes.

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NCT05960448

Autonomic Effects of Spinal Cord Stimulation in Spinal Cord Injury

Active, Not Recruiting
NAAges 18+InterventionalTreatment
James J. Peters Veterans Affairs Medical Center
~20 participants
Updated 2026-08-10 on ClinicalTrials.gov
What's tested:Transcutaneous Spinal Cord Stimulation (TSCS)Sham Transcutaneous Spinal Cord Stimulation

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Exercise Endurance Time
Measured over During procedures (30 minutes)
+3 more outcomes measured
Orthostatic Hypotension
1 sites across 1 states
New York1
  • Jill M Wecht, EdD · PRINCIPAL_INVESTIGATOR · James J. Peters Veterans Affairs Medical Center

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

You are above the age of 18 years old
You have an SCI between C3-T6
You have been injured longer than 1 year
You participated in a prior experiment "Targeted Transcutaneous Spinal Cord Stimulation to Restore Autonomic Cardiovascular Health in Individuals with Spinal Cord Injury"
You have an American Spinal Injury Association injury classification scale (AIS) A, B, C
Your prescription medications have not changed for at least 30 days

Exclusion

You have a history of seizures
You have an acute illness or infection
You have diabetes
You have untreated thyroid disease
You have a neurological condition other than SCI (Alzheimer's disease, dementia, stroke, multiple sclerosis, Parkinson's disease, etc.)
You have a history of heart or vascular disease (coronary artery disease, congestive heart failure, peripheral artery disease,)
You have a history of moderate or severe head trauma (TBI) or diagnosed with cognitive impairment
You have a present or history of a psychological disorder
You have contraindications to electricity over your spine
You are dependent on a ventilator to breathe or have an open tracheostomy site
You have a recent history of substance abuse (within the past 3 months)
You have open wounds over the spine at the level targeted for stimulation
You are pregnant
  • Exercise Endurance TimeDuring procedures (30 minutes)

    Total time (minutes) the participant is able to exercise during the submaximal arm cycle ergometry test.

  • Recovery Heart RateDuring procedures (60 minutes)

    Total time (minutes) for heart rate to return to baseline levels after submaximal exertion.

  • TcoreDuring procedures (90 minutes)

    This outcome measure is measured in degrees Celsius.

  • Thermal ComfortDuring procedures (90 minutes)

    Feeling of comfort from: +3 (very comfortable) to -3 (very uncomfortable).