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Behavioural Intervention

Transcutaneous Spinal Cord Stimulation and Gait Training for Spinal Cord Injury

N/A

Recruiting

Led By Rebecca Martin, OTR/L, OTD, CPAM

Research Sponsored by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Eligibility Criteria Checklist

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

Must have

Neurologic level above T10

Age 3-16

Timeline

Screening 3 weeks

Treatment Varies

Follow Up session 1, 6, 12, 18, and 24 (5-8 weeks total)

Awards & highlights

Study Summary

This trial aims to test the safety and feasibility of administering Transcutaneous Spinal Cord Stimulation (TSCS) to children in a clinical setting. The participants will be divided into two groups:

Who is the study for?

This trial is for children with incomplete spinal cord injuries. They will be part of a study to see if gait training combined with Transcutaneous Spinal Cord Stimulation (TSCS) helps improve their walking function compared to just gait training alone.Check my eligibility

What is being tested?

The trial tests the safety and effectiveness of TSCS in kids during an eight-week program. Kids are randomly put into two groups: one gets real TSCS plus walking exercises, and the other gets pretend stimulation (sham) plus the same exercises.See study design

What are the potential side effects?

Possible side effects include pain and skin irritation from the TSCS device. The study aims to check how safe it is by looking at these reactions as well as muscle activity changes through EMG readings.

Eligibility Criteria

Inclusion Criteria

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

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My spinal cord injury is above the T10 level.

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I am between 3 and 16 years old.

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I haven't been hospitalized in the last 3 months.

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My spinal injury is classified as moderate to mild impairment.

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I can sit or stand upright for more than 30 minutes.

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I can move one of my legs forward while standing, with support if needed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ session 1, 6, 12, 18, and 24 (5-8 weeks total)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~session 1, 6, 12, 18, and 24 (5-8 weeks total)

This trial's timeline: 3 weeks for screening, Varies for treatment, and session 1, 6, 12, 18, and 24 (5-8 weeks total) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

10-Meter Walk Test (10MWT)

6-Minute Walk Test (6MWT)

Timed Up and Go (TUG)

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Transcutaneous Spinal Cord Stimulation and Gait TrainingExperimental Treatment1 Intervention

Transcutaneous Spinal Cord Stimulation (TSCS), TSCS will be applied using an oval electrode placed midline on the skin on the back and two rectangular electrodes placed on the skin over the lower abdomen. There will be a small electrical current through those electrodes for 30 minutes.

Group II: Transcutaneous Spinal Cord Stimulation within a single sessionPlacebo Group1 Intervention

Electrodes will be placed as they are in the Transcutaneous Spinal Cord Stimulation condition. Stimulation will be applied at subject's maximum intensity for 30 seconds and then discontinued.

0 / 6Eligibility criteria met

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Who is running the clinical trial?

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.Lead Sponsor

88 Previous Clinical Trials

24,916 Total Patients Enrolled

Rebecca Martin, OTR/L, OTD, CPAMPrincipal InvestigatorHugo W. Moser Research Institute at Kennedy Krieger, Inc.

1 Previous Clinical Trials

Frequently Asked Questions

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

Which individuals are eligible to partake in this experimental study?

"Individuals aged between 3 and 16 years with a spinal cord injury are eligible for participation in this study, which aims to enroll approximately 20 participants."

Answered by AI

What is the number of participants currently involved in this clinical investigation?

"Indeed, the details on clinicaltrials.gov imply that this investigation is actively seeking eligible individuals. Initially shared on March 3rd, 2022, and most recently revised on January 29th, 2024, this research endeavor aims to recruit a total of 20 participants from one designated site."

Answered by AI

Are individuals still able to enroll in this research study at the moment?

"Affirmative. The information on clinicaltrials.gov indicates that this study is actively seeking volunteers. This research initiative was first listed on March 3rd, 2022, and most recently revised on January 29th, 2024. A total of 20 participants are being sought at a single site for enrollment in the trial."

Answered by AI

Is the research study open to participants who have reached the age of thirty?

"To be considered for participation, individuals aged between 3 and 16 years are eligible. Among the available studies, there are a total of 163 research projects catering to minors under 18 years old and 750 trials targeting individuals above the age of 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Transcutaneous Spinal Cord Stimulation in Children With Incomplete Spinal Cord Injury

Rebecca Martin, OTR/L, OTD 2022. "Transcutaneous Spinal Cord Stimulation in Children With Incomplete Spinal Cord Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06242873.