Transcutaneous Spinal Stimulation for Spinal Cord Injury

Phase-Based Progress Estimates
Kentucky Spinal Cord Injury Res Center, University of Louisville, Louisville, KYSpinal Cord InjuryTranscutaneous Spinal Stimulation - Device
2 - 15
All Sexes
What conditions do you have?

Study Summary

This trial is testing the feasibility and safety of using Transcutaneous Stimulation (TcStim) to acutely improve sitting upright in children with Spinal Cord Injury (SCI) and when used in combination with activity-based locomotor training (AB-LT).

Eligible Conditions
  • Spinal Cord Injury

Treatment Effectiveness

Study Objectives

6 Primary · 3 Secondary · Reporting Duration: 3 days for Aim 1, 9 weeks for Aim 2

Week 9
Blood pressure
Center of pressure displacement during trunk control assessment
Compliance rate
Faces Pain Scale-Revised (scale 0-10)
Heart rate
Incidence of skin irritation
Visual Analog Scale (0-10)
number of requests to stop the stimulation
Week 9
Angular excursions of trunk during trunk control assessments

Trial Safety

Trial Design

1 Treatment Group

Transcutaneous spinal stimulation
1 of 1

Experimental Treatment

9 Total Participants · 1 Treatment Group

Primary Treatment: Transcutaneous Spinal Stimulation · No Placebo Group · N/A

Transcutaneous spinal stimulation
Experimental Group · 1 Intervention: Transcutaneous Spinal Stimulation · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 3 days for aim 1, 9 weeks for aim 2

Who is running the clinical trial?

National Center of Neuromodulation for RehabilitationOTHER
9 Previous Clinical Trials
212 Total Patients Enrolled
National Center of Neuromodulation for Rehabilitation (NM4R)UNKNOWN
University of LouisvilleLead Sponsor
316 Previous Clinical Trials
73,206 Total Patients Enrolled
Andrea L Behrman, PhD, PTPrincipal InvestigatorUniversity of Louisville
1 Previous Clinical Trials
7 Total Patients Enrolled

Eligibility Criteria

Age 2 - 15 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a history of chronic spinal cord injury that affects the upper motor neurons, either from a trauma or non-traumatic cause.
You must not have completed less than 60 sessions of activity-based locomotor training/therapy at Frazier Rehab in the past.

Who else is applying?

What state do they live in?
New York100.0%
How old are they?
< 18100.0%
What site did they apply to?
Kentucky Spinal Cord Injury Res Center, University of Louisville100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%

Frequently Asked Questions

Could I be considered a viable candidate for this research endeavor?

"To participate in this clinical trial, those affected by spinal cord injuries aged between 2 and 15 are eligible. Presently, the research team is accepting a maximum of 9 individuals into the study." - Anonymous Online Contributor

Unverified Answer

Does this clinical trial admit individuals older than 30 years of age?

"The parameters for enrollment in this trial require that the patient must be between two to fifteen years of age. To date, there have been 138 trials conducted on participants younger than eighteen and 732 studies done with individuals over 65." - Anonymous Online Contributor

Unverified Answer

Is recruitment still open for the trial?

"The database reveals that this medical trial, which debuted on August 12th 2019, is not currently recruiting patients. However, there are a plethora of alternative trials with active recruitment at the moment - 903 to be precise." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.