Spinal Stimulation for Upper Extremity Recovery in the Home

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCraig Hospital

About this trial

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 criteria

Qualifiers

Age 18 or older

History of traumatic SCI

Less than 12 months post SCI

SCI injury level C1-C8

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Immediate Intervention
  • Waitlist control

Treatment groups

46 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Craig Hospital

Lead sponsor

National Institute on Disability, Independent Living, and Rehabilitation Research

Collaborator