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Recruiting NCT07911657

Functional Electrical Stimulation vs Transcutaneous Stimulation in Patients With Subacute Spinal Cord Injury

Conditions: Non Traumatic Spinal Cord Injury, Sub-Acute Rehabilitation, Spinal Cord Injury Cervical, Electric Stimulation Therapy, Upper Extremity, Recovery of Function

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 20
Sponsor: Center for Veterans Research and Education

Location: Minneapolis VA Health Care Systems Minneapolis Minnesota

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.

Eligibility Criteria

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07911657). StuddyBuddy aggregates publicly available trial information.