Status:
NOT_YET_RECRUITING
Noninvasive Spinal Stimulation to Restore Hand Function in Children with Spinal Cord Injury
Lead Sponsor:
University of Louisville
Collaborating Sponsors:
The Craig H. Neilsen Foundation
Conditions:
Spinal Cord Injury Cervical
Eligibility:
All Genders
7-12 years
Phase:
NA
Brief Summary
The main goal of this pilot study is to find the best ways to use transcutaneous spinal cord stimulation (scTS) to improve hand function in children with spinal cord injuries (SCI). The investigators ...
Detailed Description
After learning about the study and potential risks, parents/legal guardians and their eligible children with SCI will sign consent and assent forms, respectively. For the first two aims of the study, ...
Eligibility Criteria
Inclusion
- For aim 1 and 2, 10 participants with SCI:
- age 7-12 years;
- chronic (\>6 months), acquired upper motor neuron SCI;
- cervical SCI at or above C8 neurological level with motor score of 1-3 for finger flexors
- Pediatric Neurorecovery scale score of ≥2B and ≤ 4C for impaired grip
- For Aim 3, 4 participants with SCI who:
- complete aim 1 and 2;
- consent/assent for aim 3
- demonstrate a minimum of 10% increase in HG force with scTS (aim1-2)
- confirmed volitional activation in hand muscles during hang grip assessment without scTS
Exclusion
- For all 3 aims will include:
- Botox use within past 3 months (for upper or lower extremity);
- current oral baclofen (or pump);
- musculoskeletal impairment limiting range of motion;
- unhealed fracture or other medical condition limiting participation in AB-UET;
- etiology of spina bifida;
- total ventilator dependence.
Key Trial Info
Start Date :
January 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2027
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06489106
Start Date
January 1 2025
End Date
July 31 2027
Last Update
January 9 2025
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