Spinal Stimulation for Upper Extremity Recovery in the Home

Recruiting now · Not applicable

Conditions studied: Cervical Spinal Cord Injury

In brief

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).

Key facts

Study ID

NCT06743607

Run by

Craig Hospital

People needed

46

Starts

2025-05-28

Expected to finish

2027-08-01

Last updated by the study team

2026-03-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Craig Hospital — Englewood, Colorado, United States (enrolling)

Full record on ClinicalTrials.gov

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