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 @ 2:15 AM
Ignite Modification Date:
2025-12-25 @ 2:15 AM
NCT ID:
NCT02778360
Eligibility Criteria:
Inclusion Criteria:
* Children or adolescents (male or female) aged 7-13 years
* ADHD diagnosis positive with Kiddie-Sads
* ADHD RS IV \>6 for attention, with or without hyperactivity
* Patient having already had corrective actions for ADHD (formal and informal educational support, psychoeducation, psychotherapy, occupational therapy remediation, at-school programs and remediations)
* Signature of inform consent form by parent and child
* Wireless internet connection at home
Exclusion Criteria:
* ADHD hyperactive/Impulsive without inattention component
* Established diagnosis of epilepsy or other neurological disorders
* Severe and/or uncontrolled psychiatric disorder other than ADHD diagnosed with Kiddie-Sads such as autism, schizophrenia, severe generalized anxiety disorder, major depression or severe tics
* Patient with comorbid disorder requiring psychoactive medication other than ADHD medication
* Patient having already been treated with psycho-active drug (MPH and others) or EEG-NF for ADHD in the last 6 months, or more than 4 weeks more than 6 months ago
* Unable to use the solution (tablet use and/or headset set-up and/or understanding instructions) according to the investigator
* Absence of wireless internet connection at home
* Medical disorder requiring systemic chronic medication with confounding psychoactive effects
* IQ \< 80 using the 3 subtest form of the WASI or the WISC
* Plans to move requiring centre change during the next 6 months
* Plans to start other ADHD treatment, including psychotherapy, cognitive behaviour training in the next 6 months
* Patient with chronic medical illness such as seizure, cardiac disorders, untreated thyroid disease or glaucoma (contra-indication for treatment with MPH)
* Significant suicidal risk based on clinical opinion
* Patient with prescribed dietary interventions
* Patient with a known hypersensitivity to one of the ingredients of the investigational products
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
13 Years
Study:
NCT02778360
Study Brief:
Protocol Section:
NCT02778360