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 @ 7:31 PM
Ignite Modification Date:
2025-12-24 @ 7:31 PM
NCT ID:
NCT00100503
Eligibility Criteria:
* INCLUSION CRITERIA:
1. Children 9 to 17 years of age.
Cerebral palsy patients:
2. Children previously diagnosed with spastic hemiplegia subtype of cerebral palsy
3. Children with non-progressive cerebral lesions acquired pre-, peri- or post-natally, before 1 year of age.
Typically Developing subjects:
1. Scores below 60 on Connor's attention deficit/hyperactivity disorder (ADHD) checklist.
2. Normal neurological history and examination
EXCLUSION CRITERIA:
1. Any child who is pregnant
2. Patients with Development Quotient (DQ) or Intelligence Quotient (IQ) below 50 on standardized tests
Cerebral palsy patients:
3. Children with subtypes of cerebral palsy that are not hemiplegia.
4. Children with uncontrolled seizures within the last 6 months
5. Children with progressive or neurodegenerative disorders; underlying known genetic or chromosomal disorders, familial or non-familial syndromes (without known chromosomal or genetic defect)
6. Patients with cerebral lesions caused by sickle cell disease or by emboli associated with congenital cardiac lesions
7. Patients incapable of voluntary movement or with severe cognitive deficits who cannot follow simple verbal commands
Typically Developing Children:
1. Children with chronic medical disorders or any neurological and /or psychiatric disorder including attention deficit hyperactivity disorder or learning disorder
2. Children taking regular medications, including medications for allergies, hormonal oral contraceptives, or over-the-counter medications
3. Children born before 36 weeks gestation as estimated by dates, ultrasound or other methods (if a discrepancy exists, then the ultrasound estimation will be taken as definitive)
Exclusionary criteria for clinical MRI studies:
1. Any child with metal objects in the body such as pacemakers, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses, cochlear implants, or shrapnel fragments).
2. Any child with permanent tattoos on the eyelids (ferromagnetic iron oxide-based) tattoo pigments can interact with the static magnetic field of an MRI imager.
Exclusionary criteria for TMS:
1\. Children with hearing loss (greater than 15 dB at any individual frequency) in either ear (as evaluated in the Audiology Department, CC, NIH).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
17 Years
Study:
NCT00100503
Study Brief:
Protocol Section:
NCT00100503