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:
2025-12-25 @ 12:58 AM
Ignite Modification Date:
2025-12-25 @ 12:58 AM
NCT ID:
NCT03166293
Eligibility Criteria:
Inclusion Criteria:
* children aged 8 mo - 3 yr old
* Evidence of periventricular white matter injury on diagnostic imaging
* clinical evidence of spastic diplegia
Exclusion Criteria:
* born before gestational age of 25 weeks
* birth weight \<1000g (to exclude confounds related to extreme prematurity and low birth weights)
* MRI evidence of diffuse injury to the cerebral or cerebellar cortex
* uncontrolled epilepsy or infantile spasms in the past 6 months (contraindication for TMS)
* cardiovascular or musculoskeletal complications that preclude participation in intensive exercise
* Botulinum toxin (BTX-A) injections in the last 6 months
* Predicted GMFCS 4 or 5
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Months
Maximum Age:
36 Months
Study:
NCT03166293
Study Brief:
Protocol Section:
NCT03166293