Transcutaneous Spinal Stimulation for Spinal Cord Injury

Recruiting in Palo Alto (17 mi)

Overseen ByAndrea L Behrman, PhD, PT

Age: < 18

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Louisville

No Placebo Group

Approved in 2 jurisdictions

Trial Summary

What is the purpose of this trial?Paralysis of trunk muscles and the inability to sit upright is one of the major problems facing adults and children with spinal cord injury (SCI). Activity-based locomotor training has resulted in improved trunk control in children with spinal cord injury, though full recovery is not achieved in all children. Transcutaneous spinal stimulation' (TcStim), a stimulation applied over the skin to the sensory nerves and spinal cord, is a promising tool that may further enhance improvements to trunk control. The purpose of this study is to determine the feasibility (can we do it) and safety of Transcutaneous Stimulation (TcStim) in children with SCI to acutely improve sitting upright and when used with activity-based locomotor training (AB-LT). Thus, can we provide this therapy to children and do so safely examining a child's immediate response and cumulative response relative to safety and comfort. Eight participants in this study will sit as best they can with and without the stimulation (i.e. stimulation applied across the skin to the nerves entering the spinal cord and to the spinal cord) and their immediate response (safety, comfort, trunk position) recorded. Then, two participants will receive approximately 40 sessions of activity-based locomotor training in combination with the stimulation. Their cumulative response of stimulation (i.e. safety, comfort, feasibility) across time will be documented. Participation in this study may last up to 3 days for the 8 participants being observed for acute response to stimulation and up to 9 weeks for the participants being observed for cumulative response to training with stimulation. We will monitor the participants throughout the testing and training for their response to the stimulation (i.e. safety) and their comfort.

Eligibility Criteria

This trial is for children with chronic spinal cord injury who have completed at least 60 sessions of locomotor training. They should struggle to sit upright without arm support and not be using certain muscle relaxants or have unhealed fractures, recent Botox treatments, total ventilator dependence, or other complications that limit participation.

Inclusion Criteria

I have been discharged from in-patient rehab.

I have a long-term spinal cord injury affecting my muscle control.

I have completed at least 60 sessions of specific physical therapy at Frazier Rehab.

I have a long-term spinal cord injury affecting movement control.

Exclusion Criteria

I am currently taking baclofen.

I have a bone that hasn't healed yet.

I have had surgery for scoliosis.

Participant Groups

The study tests the safety and feasibility of Transcutaneous Spinal Stimulation (TcStim) in improving trunk control when sitting. It involves immediate response testing in eight children and a longer-term test with about 40 sessions combined with locomotor training in two children.

1Treatment groups

Experimental Treatment

Group I: Transcutaneous spinal stimulationExperimental Treatment1 Intervention

Safety and feasibility outcome measures are collected during application of transcutaneous spinal stimulation while trunk control is assessed at 3 time points (acute) and/or while transcutaneous stimulation is applied in combination with activity-based locomotor training (40 sessions, 1.5 hours/day, 5 days/week; stimulation will be applied intermittently for no more than 10 minutes at a time during training)

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

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