Spinal Stimulation for Upper Extremity Recovery in the Home

Trial details

Who runs it

Craig Hospital

Trial code

NCT06743607

Record updated

31 March 2026

Original description

The purpose of this research is to evaluate the safety, feasibility, and tolerability of non-invasive spinal stimulation used in the home and/or community in combination with a functional home exercise program for the upper extremities (arm/hand function) as well as their combined impacts on changes in upper extremity function. The expected duration of participation in this study is about 31-33 hours over a 13-25-week period. Enrollees in this study will be randomly assigned to one of two groups: 1) upper extremity functional task-specific training combined with non-invasive transcutaneous spinal stimulation, or 2) waitlist control, which involves the same intervention, but with a 12-week delayed start. Participants complete initial testing (one time if in group one and three times [at weeks 0, 8, and 12] if in group two), 24 1-hour training sessions (2x/week in home with caregiver/companion support and 1x/week with research team in person or via video conference for 8 weeks), a post-treatment evaluation, and a final evaluation (4 weeks after post-treatment).Read full original descriptionShow less

Spinal Stimulation to Improve Upper Extremity Recovery in the Home (SSTIM UE Recover [SURe])

The purpose of this research is to evaluate the safety, feasibility, and tolerability of non-invasive spinal stimulation used in the home and/or community in combination with a functional home exercise program for the upper extremities (arm/hand function) as well as their combined impacts on changes in upper extremity function. The expected duration of participation in this study is about 31-33 hours over a 13-25-week period. Enrollees in this study will be randomly assigned to one of two groups: 1) upper extremity functional task-specific training combined with non-invasive transcutaneous spinal stimulation, or 2) waitlist control, which involves the same intervention, but with a 12-week delayed start. Participants complete initial testing (one time if in group one and three times [at weeks 0, 8, and 12] if in group two), 24 1-hour training sessions (2x/week in home with caregiver/companion support and 1x/week with research team in person or via video conference for 8 weeks), a post-treatment evaluation, and a final evaluation (4 weeks after post-treatment).

Inclusion: Age 18 or older; History of traumatic SCI; Less than 12 months post SCI; SCI injury level C1-C8; SCI categorized as AIS B-D; Have passive range of motion (ROM) within functional limits at wrists, shoulders, and elbows; Have caregiver support to attend three in-person sessions and ongoing training at home; Have a caregiver who, in the judgment of the research team, is qualified to assist the participant in the safe use of TSS; Able to complete in-person training sessions and return to Craig Hospital for assessments; Experience no complicating physical or cognitive conditions as determined by their physician that would preclude the safe use of electrical stimulation; If using prescribed anti-spasticity medications, must be at a stable dose for at least four weeks prior to starting study procedures; Agrees to comply with investigational devices instructions for use, protocol visits, and return of the device; Able to provide informed consent.

Exclusion: Received Botox injections to the UEs, neck, or hands within the last three months; Prior nerve or tendon transfer procedure for the UEs; Concurrently are participating in another drug or device trial that may interfere with this study; Experience unstable chronic cardiac or respiratory complaints; Have a recent history of fracture, contractures, or skin pressure injuries that might interfere with the intervention; Pregnant, planning to become pregnant, or currently breastfeeding; Have breakdown in skin area that will come into contact with electrodes; Have an implanted pacemaker, spinal cord stimulator, ventriculoperitoneal shunt, deep brain stimulator, or intrathecal pump; In the opinion of the investigators, the study is not safe or appropriate for the participant.

ClinicalTrials.gov NCT06743607