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 @ 10:22 PM
Ignite Modification Date:
2025-12-24 @ 10:22 PM
NCT ID:
NCT04481035
Eligibility Criteria:
Inclusion Criteria:
1. Males and females aged 8 - 16 years at time of enrollment whom meet NIH diagnostic criteria for NF1.
2. Participants must have a full-scale intelligence quotient (IQ) of 70 or above, as determined by neurocognitive testing within the last 3 years or during the enrollment process.
3. Participants on stimulant or any other psychotropic medication should stay on a stable dose for at least 30 days before entering the study.
Exclusion Criteria:
1. Participants should not be receiving chemotherapy currently, or have received chemotherapy in the 6 months prior to entering the study.
2. No active intracranial lesions (stable low grade glioma are acceptable) or epilepsy diagnosis.
3. Major Depression, Bipolar Disorder, Conduct Disorder, Adjustment Disorder, other major Anxiety Disorders, or other developmental psychiatric diagnoses, based on the child's history or on parent and child responses from the Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS). Note that while this is an exclusion for participation in the study if there is a prior evaluation available, this becomes a criterion, after inclusion, for the investigator to withdraw the child from the study prior to completion if identified on the first study day.
4. For females, pregnancy.
5. Current use of antidepressants, non-stimulant ADHD medications, dopamine blocking agents, mood stabilizers.
6. Implanted brain stimulator, vagal nerve stimulator, ventriculoperitoneal (VP) shunt, cardiac pacemaker, or implanted medication port.
7. Asthma (bronchospasm has been reported as occurring infrequently and unpredictable when acetylcysteine is used as a mucolytica agent).
8. High risk of upper gastrointestinal (GI) hemorrhage. Examples: presence of esophageal varices or peptic ulcers
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
16 Years
Study:
NCT04481035
Study Brief:
Protocol Section:
NCT04481035