Spinal Cord Stimulation + Recovery Training for Spinal Cord Injury

Recruiting in Palo Alto (17 mi)

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Louisville

No Placebo Group

Trial Summary

What is the purpose of this trial?The purpose of this study is to deepen our understanding of children who have a cervical spinal cord injury obtained in utero or at birth and examine the effects of tailored activity-based recovery training (ABRT) in combination with transcutaneous spinal cord stimulation (scTS). This is a within subjects, pre-post design study. Neurophysiological, sensorimotor, and autonomic assessments will occur pre, interim, and post 40 sessions of ABRT in conjunction with scTs.

Eligibility Criteria

This trial is for children with a cervical spinal cord injury that occurred in the womb or at birth. They will participate in assessments before, during, and after undergoing 40 sessions of specialized recovery training combined with non-invasive spinal stimulation.

Inclusion Criteria

I have a spinal cord injury in my neck from birth.

I have been discharged from the hospital or a rehab center.

Exclusion Criteria

I am not willing to stop using my daytime back or leg braces during the study.

I experience pain from touches that are not usually painful.

I have not used Botox in the last 3 months.

+4 more

Participant Groups

The study is testing how effective activity-based recovery training (ABRT) paired with transcutaneous spinal cord stimulation (scTS) can be for young patients with early-life spinal injuries. It's a pre-post design where each child serves as their own control over time.

1Treatment groups

Experimental Treatment

Group I: Cervical Perinatal SCIExperimental Treatment2 Interventions

Participants with high cervical and low cervical SCI will perform tailored ABRT+scTS. Pre, interim, and post assessments of neurophysiological, sensorimotor, and autonomic function will be compared within-subjects and between high and low cervical SCI groups. Participants will come for daily activity-based recovery training (ABRT) + transcutaneous spinal stimulation (scTS). ABRT+scTS will take place 5 days per week for approximately 2.5 hours each (1.5 hours of lower extremity training and 1 hour of upper extremity training) for a total of 40 sessions consisting of facilitated sitting, standing, stepping, and UE motor tasks such as grasping, reaching, and hand manipulations.