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NCT03975634 · ClinicalTrials.gov registry record · NA
Transcutaneous Spinal Stimulation: Safety and Feasibility for Trunk Control in Children With Spinal Cord Injury
A NA study of Spinal Cord Injuries, sponsored by University of Louisville.
- Active
- Registry status
- NA
- Development phase
- 9
- Enrollment target
- 1
- Study location
NCT03975634 is a NA study of Spinal Cord Injuries that is active but no longer recruiting, run by University of Louisville. The registered enrollment target is 9 participants, below the 62-participant average among 202 other Spinal Cord Injuries trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03975634, a NA study of Spinal Cord Injuries, is active but no longer recruiting, sponsored by University of Louisville.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 9 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DEVICE Transcutaneous Spinal Stimulation
Study Locations (1)
Kentucky
- Kentucky Spinal Cord Injury Res Center, University of Louisville - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2019-08-12 |
| Est. Completion | 2025-06-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03975634
The ClinicalTrials.gov registry entry for NCT03975634 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 62-participant average among 202 other Spinal Cord Injuries trials with a reported enrollment target (85% lower). The listed sponsor is University of Louisville, which has 217 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Spinal Cord Injuries appearing as the primary indexed condition, and to 1 intervention - of which Transcutaneous Spinal Stimulation is the first listed.
NCT03975634 reports 1 study location spanning 1 distinct geographic area - top geographies include Kentucky.
Frequently Asked Questions
What is clinical trial NCT03975634 about?
NCT03975634 is a clinical study titled "Transcutaneous Spinal Stimulation: Safety and Feasibility for Trunk Control in Children With Spinal Cord Injury". 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...
What is the current status of trial NCT03975634?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 9 participants. The study started on 2019-08-12. Estimated completion is 2025-06-30.
What conditions does trial NCT03975634 study?
This clinical trial studies the following conditions: Spinal Cord Injuries.
What interventions are being tested in trial NCT03975634?
The interventions under investigation include: Transcutaneous Spinal Stimulation (DEVICE).
Who is sponsoring clinical trial NCT03975634?
This trial is sponsored by University of Louisville, which has 217 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03975634 being conducted?
This trial has 1 study location across Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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