Spinal Stimulation for Upper Extremity Recovery in the Home
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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).
Sponsor: Craig Hospital
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
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
Where it's recruiting
Englewood
Source: ClinicalTrials.gov · NCT06743607 · last updated 2026-03-31