Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 2:40 PM
Ignite Modification Date:
2025-12-26 @ 2:40 PM
NCT ID:
NCT06489106
Eligibility Criteria:
Inclusion Criteria:
For aim 1 and 2, 10 participants with SCI:
1. age 7-12 years;
2. chronic (\>6 months), acquired upper motor neuron SCI;
3. cervical SCI at or above C8 neurological level with motor score of 1-3 for finger flexors
4. Pediatric Neurorecovery scale score of ≥2B and ≤ 4C for impaired grip
For Aim 3, 4 participants with SCI who:
1. complete aim 1 and 2;
2. consent/assent for aim 3
3. demonstrate a minimum of 10% increase in HG force with scTS (aim1-2)
4. confirmed volitional activation in hand muscles during hang grip assessment without scTS
Exclusion Criteria:
For all 3 aims will include:
1. Botox use within past 3 months (for upper or lower extremity);
2. current oral baclofen (or pump);
3. musculoskeletal impairment limiting range of motion;
4. unhealed fracture or other medical condition limiting participation in AB-UET;
5. etiology of spina bifida;
6. total ventilator dependence.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
12 Years
Study:
NCT06489106
Study Brief:
Protocol Section:
NCT06489106