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Clinical Trial

Transcutaneous Spinal Stimulation: Safety and Feasibility for Trunk Control in Children With Spinal Cord Injury

NCT: NCT03975634 · COMPLETED

NCT IDNCT03975634
StatusCOMPLETED
Start Date2019-08-12
Completion2022-06-30
SponsorUniversity of Louisville (OTHER)
First posted
Last updated

Brief Summary

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.

Frequently Asked Questions

What is Transcutaneous Spinal Stimulation: Safety and Feasibility for Trunk Control in Children With Spinal Cord Injury?

Transcutaneous Spinal Stimulation: Safety and Feasibility for Trunk Control in Children With Spinal Cord Injury is a clinical trial registered under NCT03975634. Current status: COMPLETED.

What is the status of NCT03975634?

The current status of NCT03975634 (Transcutaneous Spinal Stimulation: Safety and Feasibility for Trunk Control in Children With Spinal Cord Injury) is: COMPLETED.

When did Transcutaneous Spinal Stimulation: Safety and Feasibility for Trunk Control in Children With Spinal Cord Injury start?

Transcutaneous Spinal Stimulation: Safety and Feasibility for Trunk Control in Children With Spinal Cord Injury started on 2019-08-12.

Official Source

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Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.