What this study is
Simplified from ClinicalTrials.govTesting sticky skin pads over the spine that give electrical stimulation (transcutaneous spinal stimulation) to improve arm and hand function in veterans 18 or older with subacute non-traumatic spinal cord injury who are in hospital rehab. It is compared with functional electrical stimulation, which places the pads over the arm muscles.
Read the original summary from ClinicalTrials.gov
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.
What's being tested
- RTI Xcite
Intervention · DEVICE
Functional electrical stimulation
- ExaStim
Intervention · DEVICE
Transcutaneous spinal stimulation
Study details
- Official title
- Comparison of Traditional Functional Electrical Stimulation to Transcutaneous Stimulation on Upper Extremity Outcomes in Patients With Subacute Spinal Cord Injury
- Sponsor
- Center for Veterans Research and Education
- Conditions
- Non Traumatic Spinal Cord Injury · Sub-Acute Rehabilitation · Spinal Cord Injury Cervical · Electric Stimulation Therapy · Upper Extremity · Recovery of Function
- Enrolling
- 20 people
- Starts
- 2026-06-18
- Est. completion
- 2030-06-01
- Design
- Single-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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+.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openMinneapolis VA Health Care Systems
Minneapolis, Minnesota, United States
- Jennifer L Robb, PhD · Contact(763) 346-9826Jennifer.Robb2@va.gov
- John M Looft, PhD · Principal investigator
Recruiting
Study team
Sponsor
Center for Veterans Research and Education
Study ID 1904131
Principal investigator
John M Looft, PhD
Minneapolis VA
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.