Spinal Stimulation for Spinal Cord Injury
(SURe Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Craig Hospital

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of 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

This trial is for individuals with spinal cord injuries or a broken neck who are looking to improve their arm and hand functions. Participants should be able to commit to a 13-25 week program involving home exercises with caregiver support.

Inclusion Criteria

I can move my wrists, shoulders, and elbows normally.

My spinal cord injury is partially severe but not complete.

I have someone to help me with attending sessions and training at home.

+10 more

Exclusion Criteria

Pregnant, planning to become pregnant, or currently breastfeeding

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

+6 more

Participant Groups

The study tests if non-invasive spinal stimulation combined with functional home exercise can enhance upper extremity function. Half the participants start immediately, while the other half wait 12 weeks before beginning the same treatment.

2Treatment groups

Active Control

Group I: Immediate InterventionActive Control1 Intervention

For the immediate intervention group, each participant will complete the following: * Initial baseline evaluation * 24 training sessions (3x/week for eight weeks) of UE Functional Task Practice (FTP)+TSS (two training sessions/week will be completed in the home with caregiver/companion support; the third weekly session will be conducted via videoconference with a research therapist) * Post-treatment evaluation (after eight weeks of training) and follow-up evaluation (four weeks after post-treatment evaluation). * Post-treatment and follow-up assessments will be conducted over two days: assessments completed without TSS on day one and with TSS on day two.

Group II: Waitlist ControlActive Control1 Intervention

The waitlist control group will participate in a protocol similar to the immediate intervention group, except: * 12-week waiting period before starting the active intervention. * Assessments will be completed at 0, 8, and 12 weeks before starting the active intervention to control for spontaneous recovery. * Post-treatment evaluation (after eight weeks of training) * Follow-up assessment (four weeks after the post-treatment evaluation).

Spinal Stimulation is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Spinal Cord Stimulation for: