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Transcutaneous Spinal Cord Stimulation in Children With Incomplete Spinal Cord Injury

RecruitingNAAges 3 Years - 16 YearsAllHugo W. Moser Research Institute at Kennedy Krieg…
NCT06242873 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Aim 1: Determine the safety and feasibility of administration of TSCS to children in a clinical setting. Participants will be randomly assigned to experimental (TSCS) or control (sham stimulation) groups. Both groups will receive eight-weeks of individualized gait training. We will measure adverse events, including pain and skin irritation, to determine safety as the primary outcome. Hypothesis 1: Administration of TSCS to children in a clinical setting will be safe based on similar safety outcomes as sham TSCS. Hypothesis 2: TSCS is feasible based on compliance to session interventions and long-term adherence to the protocol. Additionally, we will collect data on effort during sessions of both participant and therapist. We anticipate that the participants will report less effort in the experimental condition, as compared to the control and therapists will report equal effort across cond

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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
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What it tests

  • Gait training with/without TSCS
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Where

1 site
Kennedy Krieger Institute
Baltimore, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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