Overview
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.
Description
Cervical spinal cord injuries (SCI) are the most prevalent form of spinal cord injuries within the veteran population. Cervical spinal cord injuries can result in functional limitations to both the lower and upper extremities. Among cervical SCI patients, addressing loss of function in the upper extremities is an extremely important issue to address. Current strategies to treat cervical spinal cord injuries during sub-acute rehabilitation incorporate functional electrical stimulation (FES), with electrodes placed on the skin directly over the targeted muscle groups. With this study current standard care FES will be compared with a new type of muscle stimulation - transcutaneous spinal stimulation (TSS) using the ExaStim® Stimulation System - where electrodes are placed on the skin over the spine. This study is a randomized controlled trial comparing the experimental use of TSS vs FES/standard care among veterans with non-traumatic spinal cord injury during their inpatient sub-acute stay. Outcome evaluations include physical outcome measures and patient-reported outcomes. The primary outcome measure is the Capabilities of Upper Extremity Test. Data will be collected by staff who are blinded to participants' group assignment. This study will provide evidence on the potential benefits of a promising new rehabilitation treatment modality - TSS - for supporting veterans with cervical SCI in achieving optimal outcomes in function and independence.
Eligibility
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.
