Recruiting

FES vs. TSS

Sponsor:

Center for Veterans Research and Education

Code:

NCT07911657

Conditions

Non Traumatic Spinal Cord Injury

Sub-Acute Rehabilitation

Spinal Cord Injury Cervical

Electric Stimulation Therapy

Upper Extremity

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

RTI Xcite

ExaStim

Study Details

Brief summary:

Cervical spinal cord injuries (SCI) are the most common form of spinal cord injuries within the veteran population. Losing arm function is a major concern with these injuries. Doctors often use a treatment called functional electrical stimulation (FES) during rehab sessions targeted at improving arm and hand function. For FES, clinicians places sticky pads on the skin over the muscles that need to move. A newer treatment, called transcutaneous spinal stimulation (TSS), places the pads on the skin over the spine instead. This study compares the two treatments in veterans with non-traumatic spinal cord injuries while they are in the hospital's rehab program. The main goal is to see how well each treatment improves arm and hand function, which is measured with the Capabilities of Upper Extremity Test. If TSS works well, it could help veterans regain more arm and hand function which may result in increased independence.

Conditions

Non Traumatic Spinal Cord Injury

Sub-Acute Rehabilitation

Spinal Cord Injury Cervical

Electric Stimulation Therapy

Upper Extremity

Study ID

NCT07911657

Start date

Jun 18, 2026

Status verified date

Oct, 2026

Completion date

Jun 1, 2030

Anticipated

Primary completion date

Jun 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • • Veterans admitted to the Minneapolis VA Health Care System's (MVAHCS) SCI inpatient unit for sub-acute rehabilitation following non-traumatic cervical SCI.

  • Veterans are eligible for enrollment within 90 days of the onset of their spinal cord injury.
  • Non-traumatic SCI, level T2 or above; AIS A,B,C,D.
  • Age 18+.

Exclusion Criteria:

  • • Study clinicians determine that the veteran would likely not benefit from FES.

  • Open wounds where electrodes would be placed.
  • Cognitive impairments identified during the consent process indicating a veteran's Inability to comprehend essential information about the study.
  • Contraindications to electrical stimulation (pacemaker, defibrillator, pregnancy, active tissue infection in area of stimulation).
  • Active implanted medical device for electrical stimulation.
  • Other internal metallic objects of unknown or foreign origin (unidentifiable surgical implants, shrapnel, bullet fragments, etc.)
  • Acute medical conditions under active treatment that would contraindicate standard rehabilitation." History of a non-SCID related neurological condition (stroke, brain injury, etc.) impacting upper extremity.
  • Uncontrolled, severe autonomic dysreflexia.
  • Need for ventilator support.
  • Inability to participate in therapy session >60 minutes.
  • Botulinum toxin injections to the upper limb in prior 3 months.
  • BMI > 40.0 (morbid obesity).
  • Allergy to hydrogel, silicone, latex or other product materials.
  • Uncontrolled cardiopulmonary disease.
  • Uncontrolled epilepsy or seizures.
  • Unmanaged depression, psychiatric disorders or ongoing substance abuse.
  • Participation in another clinical trial that may interfere with this study.
  • Pregnancy is contra-indicated for both TSS and FES. Women of childbearing years will be excluded as the enrollment timeline won't allow time for pregnancy testing.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Functional electrical stimulation

RTI Xcite

experimental: Transcutaneous spinal stimulation

ExaStim

Interventions

RTI Xcite

Functional electrical stimulation

ExaStim

Transcutaneous spinal stimulation

Primary outcome measure

  • Capabilities of Upper Extremity Test (CUE-T) [ Time Frame: Baseline, 4-week, 8-week ]

Central Contacts and Locations

Central contacts

Katherine Metcalf

612-467-3538Katherine.Metcalf@va.gov

Locations

Minneapolis VA Health Care Systems

Recruiting

Minneapolis, Minnesota, United States, 55417

Contacts

Jennifer L Robb, PhD

(763) 346-9826Jennifer.Robb2@va.gov

Principal Investigator:

John M Looft, PhD

More Information

Sponsor

Center for Veterans Research and Education

Last update posted

Nov 3, 2026

Last verified

Oct, 2026

Keywords

  • Cervical spinal cord injury
  • Non-traumatic spinal cord injury
  • Veterans
  • Upper extremity function
  • Sub-acute rehabilitation
  • Functional electrical stimulation
  • Transcutaneous spinal stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-04. This information was provided to ClinicalTrials.gov by Center for Veterans Research and Education on 2026-11-03. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.