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Transcutaneous Spinal Cord Stimulation for Children with Incomplete Spinal Cord Injury

This study is looking at a treatment called Transcutaneous Spinal Cord Stimulation (TSCS) for children aged 3 to 16 who have an incomplete spinal cord injury (meaning they still have some feeling or movement below the injury). The study aims to see if TSCS, when combined with gait training (walking practice), is safe and helps improve walking ability. Participants will be randomly assigned to either receive TSCS or a sham (inactive) stimulation, along with 8 weeks of individualized gait training. Researchers will measure walking ability using tests like the Timed Up and Go and the 10-Meter Walk Test. The study is currently unclear on its recruitment status and plans to enroll 20 children.

Study design
This is an interventional study that will randomly assign 20 participants to either receive Transcutaneous Spinal Cord Stimulation or a sham stimulation. Both groups will receive individualized gait training.
What's involved
Participants will attend 24 sessions over 5-8 weeks. Two sessions will be for assessment, and 22 sessions will involve two hours of therapy.
Compensation
Not stated in the trial record.
Follow-up
Walking ability will be measured at sessions 1, 6, 12, 18, and 24, which covers a total of 5-8 weeks.

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NCT06242873

Transcutaneous Spinal Cord Stimulation in Children With Incomplete Spinal Cord Injury

Recruiting
NAAges 3–16InterventionalTreatment
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
~20 participants
Updated 2026-03-02 on ClinicalTrials.gov
What's tested:Gait training with/without TSCS

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Timed Up and Go (TUG)
Measured over session 1, 6, 12, 18, and 24 (5-8 weeks total)
+3 more outcomes measured

Conditions

Spinal Cord Injuries

Explore related trials

Spinal Cord Injury

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Rebecca Martin, OTR/L, OTD, CPAM · PRINCIPAL_INVESTIGATOR · Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Who to contact

Shannon M Inches
[email protected]
443-923-9235
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age 3-16
≥ 6 months post injury
Non-progressive SCI
American Spinal Injury Association Impairment Scale (AIS) Classification C or D AIS C is an incomplete classification where more than half of the key muscles below the neurological level have a muscle grade of 3 or less AIS D is an incomplete classification where more than half of the key muscles below the neurological level have a muscle grade of more than 3
Neurologic level above T10
Tolerates upright position for \>30 minutes
Able to advance one lower extremity (LE) when in standing, bracing and assistive device allowed
Medically stable (no hospitalizations in last 3 mos.)
Able to comply with The International Standards for neurological and functional Classification of Spinal Cord Injury (ISNCSCI) exam

Exclusion

Progressive Spinal Cord Injury or Disease (SCI/D) (Multiple Sclerosis, Acute Disseminated Encephalomyelitis, etc.)
Active wounds
Range of motion limits impacting gait training
Cardiac pacemaker/defibrillator
Active cancer diagnosis
Absent LE reflexes
Pregnancy

What this trial measures

  • Timed Up and Go (TUG)session 1, 6, 12, 18, and 24 (5-8 weeks total)

    Measures walking function, balance, and mobility.

  • 10-Meter Walk Test (10MWT)session 1, 6, 12, 18, and 24 (5-8 weeks total)

    Measures walking speed.

  • Walking Index for Spinal Cord Injury II (WISCI II)session 1, 6, 12, 18, and 24 (5-8 weeks total)

    Measures walking quality, including need for assistive device and physical assistance.

  • 6-Minute Walk Test (6MWT)session 1, 6, 12, 18, and 24 (5-8 weeks total)

    Measures walking endurance