Electrical stimulation for arm function after cervical spinal cord injury in veterans

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized controlled trial compares two non-invasive stimulation approaches for improving upper-extremity function in veterans with cervical spinal cord injuries during sub-acute inpatient rehabilitation. Participants receive either ExaStim-based transcutaneous spinal stimulation or conventional FES while performing rehab activities, with outcomes assessed by blinded staff. The primary outcome is the Capabilities of Upper Extremity Test, complemented by additional physical and patient-reported measures. Data collection is conducted in the Minneapolis VA Health Care System, and results will inform whether TSS offers a meaningful advantage over standard FES. The study addresses a key disability area for veterans and may influence rehabilitation practices if effective.

Why it matters

Who can join: the full rules

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.

Where it's running

• Minneapolis VA Health Care Systems
  Minneapolis, Minnesota, United States Recruiting

Study contacts

• Principal investigator: John M Looft, PhD — Minneapolis VA
• Study coordinator: Katherine Metcalf
• Email: Katherine.Metcalf@va.gov
• Phone: 612-467-3538

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.