Transcutaneous spinal cord stimulation for children with incomplete spinal cord injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the safety and feasibility of transcutaneous spinal cord stimulation (TSCS) in children aged 3 to 16 with incomplete spinal cord injuries. Participants will be randomly assigned to receive either TSCS or sham stimulation while undergoing eight weeks of individualized gait training. The primary outcomes will focus on measuring adverse events and compliance with the intervention protocol. Additionally, the study will assess the neurophysiologic impact of TSCS during a single session.

Why it matters

Who can join: the full rules

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

Where it's running

• Kennedy Krieger Institute
  Baltimore, Maryland, United States Recruiting

Study contacts

• Principal investigator: Rebecca Martin, OTR/L, OTD, CPAM — Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
• Study coordinator: Shannon M Inches
• Email: inches@kennedykrieger.org
• Phone: 443-923-9235

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.