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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

No Placebo-Only Group

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.

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.

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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Angular excursions of trunk during trunk control assessments

Blood pressure

Faces Pain Scale-Revised (scale 0-10)

+3 more

Secondary study objectives

Center of pressure displacement during trunk control assessment

Compliance rate

Heart rate

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 7Eligibility criteria met