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Transcutaneous Spinal Stimulation for Spinal Cord Injury

N/A
Waitlist Available
Led By Andrea L Behrman, PhD, PT
Research Sponsored by University of Louisville
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
discharged from in-patient rehabilitation
history of chronic, acquired upper motor neuron SCI (traumatic or non-traumatic);
Must not have
Current baclofen use
Unhealed fracture
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 days for aim 1, 9 weeks for aim 2
Awards & highlights

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).

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects are not listed, the study closely monitors safety and comfort during stimulation to assess any adverse reactions related to TcStim therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been discharged from in-patient rehab.
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I have a long-term spinal cord injury affecting my muscle control.
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I have completed at least 60 sessions of specific physical therapy at Frazier Rehab.
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I have a long-term spinal cord injury affecting movement control.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently taking baclofen.
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I have a bone that hasn't healed yet.
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I have had surgery for scoliosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 days for aim 1, 9 weeks for aim 2
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 days for aim 1, 9 weeks for aim 2 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Angular excursions of trunk during trunk control assessments
Blood pressure
Faces Pain Scale-Revised (scale 0-10)
+3 more
Secondary outcome measures
Center of pressure displacement during trunk control assessment
Compliance rate
Heart rate

Trial Design

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)

Find a Location

Who is running the clinical trial?

National Center of Neuromodulation for Rehabilitation (NM4R)UNKNOWN
University of LouisvilleLead Sponsor
340 Previous Clinical Trials
77,361 Total Patients Enrolled
National Center of Neuromodulation for RehabilitationOTHER
10 Previous Clinical Trials
202 Total Patients Enrolled

Media Library

Transcutaneous Spinal Stimulation (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03975634 — N/A
Spinal Cord Injury Research Study Groups: Transcutaneous spinal stimulation
Spinal Cord Injury Clinical Trial 2023: Transcutaneous Spinal Stimulation Highlights & Side Effects. Trial Name: NCT03975634 — N/A
Transcutaneous Spinal Stimulation (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03975634 — N/A
~2 spots leftby Jul 2025
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