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Neuromodulation

Neuromodulation Therapy for Spinal Cord Injury

N/A

Waitlist Available

Led By Andrea L Behrman, PT, PhD

Research Sponsored by University of Louisville

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Unable to stand, walk, or initiate steps

Age 4-12 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change in limb angle excursions: pre-stimulation compared to during-stimulation during session 1, session 2, session 3, and session 4 within 1 month of initiation and at session 1, 20, 40, and 60 within a 4 month period

Awards & highlights

Study Summary

This trial is investigating the use of transcutaneous spinal stimulation (TcStim) to help children with chronic spinal cord injury (SCI) be able to walk again.

Who is the study for?

This trial is for children aged 4-12 with chronic spinal cord injury (SCI) at T10 or above, who can't stand, walk, or initiate steps. They must be more than a year post-injury and discharged from inpatient rehab. Kids with recent Botox use, scoliosis surgery after SCI, congenital SCI, baclofen treatments, musculoskeletal issues affecting movement, unhealed fractures or total ventilator dependence cannot join.Check my eligibility

What is being tested?

The study tests if transcutaneous spinal stimulation (TcStim), using the Biostim-5 device combined with locomotor training can help children step again after an SCI. It will explore how this method affects the spinal circuitry during stepping tasks and whether it improves their ability to step over time.See study design

What are the potential side effects?

Potential side effects of TcStim may include discomfort at the stimulation site, skin irritation under electrode pads and muscle fatigue due to exercise involved in locomotor training.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I cannot stand, walk, or start walking on my own.

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I am between 4 and 12 years old.

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My child has had a spinal cord injury above T10 for over a year.

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I have been discharged from inpatient rehab.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change in ability to voluntarily step comparing pre-stimulation to during and post stimulation during session 1, session 2, session 3, and session 4 within 1 month of initiation and at session 1, 20, 40, and 60, within a 4 month period

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change in ability to voluntarily step comparing pre-stimulation to during and post stimulation during session 1, session 2, session 3, and session 4 within 1 month of initiation and at session 1, 20, 40, and 60, within a 4 month period

This trial's timeline: 3 weeks for screening, Varies for treatment, and change in ability to voluntarily step comparing pre-stimulation to during and post stimulation during session 1, session 2, session 3, and session 4 within 1 month of initiation and at session 1, 20, 40, and 60, within a 4 month period 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 lower extremity

Electromyography (EMG) recording of lower extremity and trunk muscles

Movement observation (live observation) with video review of the ability to initiate and take an independent, voluntary step from a position of standing.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Transcutaneous Spinal Stimulation- Acute and with Training.Experimental Treatment2 Interventions

For Aim 1: Participants will receive transcutaneous stimulation (TcStim) in supine or side lying position at a single or multi site spinal levels to produce stepping/locomotor activity in lower limbs. For Aim 2: TcStim will be delivered while participants are stepping on a computerized treadmill with an overhead partial body weight support (BWS) system and while stepping overground. For Aim 3: Participants will first receive a combination of Activity-based locomotor training (AB-LT)+TcStim for 60 sessions.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Kosair Charities, Inc.OTHER

3 Previous Clinical Trials

106 Total Patients Enrolled

Kentucky Spinal Cord and Head Injury Research Trust and BoardUNKNOWN

University of LouisvilleLead Sponsor

338 Previous Clinical Trials

75,976 Total Patients Enrolled

Media Library

Transcutaneous Spinal Stimulator (Neuromodulation) Clinical Trial Eligibility Overview. Trial Name: NCT04077346 — N/A

Spinal Cord Injury Research Study Groups: Transcutaneous Spinal Stimulation- Acute and with Training.

Spinal Cord Injury Clinical Trial 2023: Transcutaneous Spinal Stimulator Highlights & Side Effects. Trial Name: NCT04077346 — N/A

Transcutaneous Spinal Stimulator (Neuromodulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04077346 — N/A

Frequently Asked Questions

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

Can I be accepted into this research initiative?

"This trial is accepting 8 children, aged between 4 and 12 years old with spinal cord injuries that have persisted for at least a year. To be eligible, participants must have an upper motor neuron injury above T10 level, caused by either trauma or non-trauma; they must also have completed inpatient rehabilitation but still lack the ability to stand up or take steps independently."

Answered by AI

Is this experiment accommodating participants aged eighty or above?

"This research project is only open to children between the ages of 4 and 12. There are 138 studies available for minors below 18 years old, while 735 trials accommodate elderly participants over 65."

Answered by AI

Is enrollment available for this research project?

"According to clinicaltrials.gov, this particular medical trial is no longer seeking enrollees; the initial post was dated April 12th 2021 and the latest update occurred on May 24th 2022. However, 906 other studies are actively recruiting patient volunteers at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Neuromodulation of Spinal Locomotor Circuitry to Elicit Stepping After Pediatric Spinal Cord Injury

Andrea L. Behrman, PhD, PT 2021. "Neuromodulation of Spinal Locomotor Circuitry to Elicit Stepping After Pediatric Spinal Cord Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04077346.

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