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:
2025-12-24 @ 3:34 PM
Ignite Modification Date:
2025-12-24 @ 3:34 PM
NCT ID:
NCT02250092
Eligibility Criteria:
Inclusion Criteria:
1. Hemispheric Stroke or Periventricular Leukomalacia confirmed by most recent MRI or CT radiologic report with resultant congenital hemiparesis
2. ≥ 10 degrees of active motion at the metacarpophalangeal joint
3. Receptive language function to follow two-step commands as evidenced by performance on TOKEN test of intelligence
4. No evidence of seizure activity within the last 2 years
5. Presence of a motor evoked potential from at least the contralesional hemisphere if not both hemispheres
6. Ages 8-21 years
7. Able to give informed assent along with the informed consent of the legal guardian
8. Children who have had surgeries, which may influence motor function eg- tendon transfer, will be included, yet surgical history will be documented and included in any publication within a participant characteristics table.
Exclusion Criteria:
1. Metabolic Disorders
2. Neoplasm
3. Epilepsy
4. Disorders of Cellular Migration and Proliferation
5. Acquired Traumatic Brain Injury
6. Pregnancy
7. Indwelling metal or incompatible medical devices
8. Evidence of skin disease or skin abnormalities
9. Botulinum toxin or Phenol block within \[six-months\] preceding the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
21 Years
Study:
NCT02250092
Study Brief:
Protocol Section:
NCT02250092