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 @ 12:21 AM
Ignite Modification Date:
2025-12-25 @ 12:21 AM
NCT ID:
NCT04569058
Eligibility Criteria:
Inclusion Criteria:
* Male or female participants between 9 and 17 years of age (inclusive)
* Participant fulfills Diagnostic and Statistical Manual of Mental Disorders-5 diagnostic criteria for Attention Deficit Hyperactivity Disorder as established by the clinical diagnostic interview.
* Participants with at least moderate severity of Autism Spectrum Disorder symptoms as demonstrated by Social Responsiveness Scale raw score ≥ 75 or Clinician Global Impression-Autistic Traits severity score ≥ 4
* Participants must understand the nature of the study. Participants must sign an Institutional Review Board-approved informed consent form before initiation of any study procedures.
* Participants are willing and able to cooperate with all tests, examinations and demonstrate ability to appropriately administer the study treatment required by the protocol.
* Participants must have access to a computer with camera and broadband internet connection
Exclusion Criteria:
* Impaired intellectual capacity (clinically determined)
* Serious chronic medical or psychiatric condition that, in the investigator's opinion, puts the subject at risk
* The subject has a significant skin condition at the procedure sites (i.e., hemangioma, scleroderma, psoriasis, rash, open wound or tattoo)
* The subject has an implant of any kind in the head (e.g. stent, clipped aneurysm, embolised AVM, implantable shunt - Hakim valve)
* Any use of light-activated drugs (photodynamic therapy) within 14 days prior to study enrollment including: Visudine (verteporfin) - for age related macular degeneration; Aminolevulinic Acid- for actinic keratoses; Photofrin (porfimer sodium) - for esophageal cancer, non-small cell lung cancer; Levulan Kerastick (aminolevulinic acid HCl) - for actinic keratosis; 5-aminolevulinic acid; and (ALA)- for non-melanoma skin cancer
* Current treatment with a psychotropic medication on a dose that has not been stable for at least 4 weeks prior to initiating study treatment.
* Pregnant or nursing females
* Investigator and his/her immediate family
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
9 Years
Maximum Age:
17 Years
Study:
NCT04569058
Study Brief:
Protocol Section:
NCT04569058