Transcutaneous spinal cord stimulation for children with incomplete spinal cord injury
Transcutaneous Spinal Cord Stimulation in Children With Incomplete Spinal Cord Injury: Safety, Feasibility, and Efficacy.
This study is testing if a new type of spinal cord stimulation can help children aged 3 to 16 with incomplete spinal cord injuries improve their walking while they receive special training.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 3 Years to 16 Years |
| Sex | All |
| Sponsor | Hugo W. Moser Research Institute at Kennedy Krieger, Inc. Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT06242873 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children aged 3-16 who are at least six months post-injury and have a non-progressive spinal cord injury classified as AIS C or D.
Not a fit: Patients with progressive spinal cord injuries or those with active wounds may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance gait training outcomes and improve mobility for children with incomplete spinal cord injuries.
How similar studies have performed: While the specific application of TSCS in children is novel, similar approaches in adults have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Baltimore, Maryland
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.