← Back to Search

Other

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);

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 days for aim 1, 9 weeks for aim 2

Awards & highlights

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).

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

Select...

I have been discharged from in-patient rehab.

Select...

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

Select...

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

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 days for aim 1, 9 weeks for aim 2

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)

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Center of Neuromodulation for Rehabilitation (NM4R)UNKNOWN

University of LouisvilleLead Sponsor

336 Previous Clinical Trials

75,931 Total Patients Enrolled

National Center of Neuromodulation for RehabilitationOTHER

10 Previous Clinical Trials

222 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

Is recruitment still open for the trial?

"The clinicaltrials.gov 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."

Answered by AI