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 @ 3:33 AM
Ignite Modification Date:
2025-12-25 @ 3:33 AM
NCT ID:
NCT04895605
Eligibility Criteria:
Inclusion Criteria:
* Male or female child or adolescent aged 5 to 12 years
* Subject has met Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) for autistic disorder within the past 2 years, as diagnosed by a trained, qualified medical professional such as a pediatric neurologist, child psychiatrist or developmental pediatrician Diagnosis is confirmed by Autism Diagnostic Interview (ADI-R)
* Subject demonstrates 'irritable' behaviors such as tantrums, aggression, self-injurious behavior, or a combination of such behaviors
* Subject's Aberrant Behavior Checklist (ABC) Irritability Subscale score is \>=18
* Subject's Clinical Global Impressions - Severity (CGI-S) scale score is \>=4 (4=moderately ill)
* Subject's current therapeutic/intervention plan for treating his or her autistic disorder (educational/behavioral or other therapy; medication use; dietary interventions) has been consistent/stable over at least the past 3 months and the subject's caregiver agrees, and it is possible for, the subject to maintain his or her current therapeutic/intervention plan throughout participation in the clinical study.
* Subject's caregiver agrees, and it is possible for, the subject to abstain from partaking in new treatments to treat the subject's autistic disorder symptoms during participation in the study. This includes educational/behavioral therapy, dietary interventions, medications such as FDA-approved Risperdal® and Abilify® and other medications often prescribed for the treatment of other autism-related symptoms, such as anxiety, depression, or obsessive-compulsive disorder, including antipsychotic medications used to treat severe behavioral problem, and medications used to treat people with attention deficit disorder
Exclusion Criteria:
* Subject has a primary or concurrent diagnosis of another disorder or other identifiable genetic condition associated with the autism spectrum scale or with mental retardation, including:
PDD-NOS Asperger's Disorder Rett's Disorder Fragile-X Syndrome Childhood Disintegrative Disorder Down Syndrome
* Seizure disorders (active), cerebrovascular disease or brain trauma as etiology of autistic behavior
* Current diagnosis of, and treatment for, bipolar disorder, psychosis, schizophrenia, or major depression
* Known neurological disease, such as encephalitis
* Significant sensory or motor impairment such as cerebral palsy
* Diagnosis of epilepsy that is currently treated with anti-convulsant medication
* Previous significant head trauma
* Hearing loss requiring use of assistive devices such as hearing aids or cochlear implant
* Significant visual impairment that cannot be adequately corrected with lenses
* Documented mental age younger than 18 months
* HIV and other autoimmune disorders
* Active cancer or treatment for cancer within last 6 months
* Unstable cardiac disease, such as a recent cardiac arrhythmia (including atrial fibrillation, ventricular fibrillation and irregular atrial-ventricular conduction time), or recent congestive heart failure, or recent myocardial infarction
* Previous surgical interventions to the head/neck area
* Sensitivity to, or contraindication for, light therapy
* Participation in a research study within the past 30 days
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
12 Years
Study:
NCT04895605
Study Brief:
Protocol Section:
NCT04895605