Actively Recruiting
Spinal Stimulation for Upper Extremity Recovery in the Home
Led by Craig Hospital · Updated on 2026-03-31
46
Participants Needed
1
Research Sites
113 weeks
Total Duration
On this page
Sponsors
C
Craig Hospital
Lead Sponsor
N
National Institute on Disability, Independent Living, and Rehabilitation Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Spinal Stimulation for Upper Extremity Recovery in the Home
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 or older
- History of traumatic spinal cord injury
- Less than 12 months post spinal cord injury
- Spinal cord injury level between C1 and C8
- Injury classified as AIS B-D
- Have passive range of motion within functional limits at wrists, shoulders, and elbows
- Have caregiver support to attend three in-person sessions and ongoing home training
- Caregiver qualified to assist with safe use of transcutaneous spinal stimulation
- Able to complete in-person training sessions and return for assessments
- No complicating physical or cognitive conditions preventing safe electrical stimulation
- Stable dose of prescribed anti-spasticity medications for at least four weeks prior to starting
- Agree to comply with device instructions, protocol visits, and device return
- Able to provide informed consent
You will not qualify if you...
- Unstable chronic cardiac or respiratory complaints
- Recent fracture, contractures, or skin pressure injuries interfering with intervention
- Botox injections to upper extremities, neck, or hands within last three months
- Pregnant, planning pregnancy, or currently breastfeeding
- Breakdown in skin area contacting electrodes
- Prior nerve or tendon transfer procedure for upper extremities
- Participating in another drug or device trial that may interfere
- Have implanted pacemaker, spinal cord stimulator, ventriculoperitoneal shunt, deep brain stimulator, or intrathecal pump
- Study deemed unsafe or inappropriate for participant by investigators
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Craig Hospital
Englewood, Colorado, United States, 80113
Actively Recruiting
Research Team
C
Candy Tefertiller, PT, DPT, PhD, NCS
CONTACT
B
Bria Mellick, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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