RecruitingNot ApplicableNCT06743607

Spinal Stimulation for Upper Extremity Recovery in the Home

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

Sponsor

Craig Hospital

Enrollment

46 participants

Start Date

May 28, 2025

Study Type

INTERVENTIONAL

Conditions

Cervical Spinal Cord Injury

Summary

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).

Eligibility

Min Age: 18 Years

Inclusion Criteria13

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 Criteria9

Experience unstable chronic cardiac or respiratory complaints
Have a recent history of fracture, contractures, or skin pressure injuries that might interfere with the intervention
Received Botox injections to the UEs, neck, or hands within the last three months
Pregnant, planning to become pregnant, or currently breastfeeding
Have breakdown in skin area that will come into contact with electrodes
Prior nerve or tendon transfer procedure for the UEs
Concurrently are participating in another drug or device trial that may interfere with this study
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

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Interventions

BEHAVIORALImmediate Intervention

Participants will engage in a home exercise therapy program in combination with transcutaneous spinal stimulation intended to focus on the upper extremities that commences immediately after enrollment.

BEHAVIORALWaitlist control

Participants will engage in a home exercise therapy program in combination with transcutaneous spinal stimulation intended to focus on the upper extremities that commences 12 weeks after enrollment.