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 @ 11:56 PM
Ignite Modification Date:
2025-12-24 @ 11:56 PM
NCT ID:
NCT05435651
Eligibility Criteria:
Inclusion Criteria:
* Age 8 years to 12 years, inclusive, at the time of parental informed consent.
* Male or female.
* Confirmed ADHD diagnosis , any presentation , at Screening based on DSM-V criteria and established via the MINI-KID administered by a trained clinician.
* Screening/Baseline score on the clinician-rated ADHDRS-IV score 24.
* Screening/Baseline score on the TOVA API -1.8.
* Not undergoing pharmacological treatment with methylphenidate or amphetamine-based products at time of Screening ; or, if undergoing pharmacolog ical treatment , must be willing and appropriate (i.e. not optimally treated in the investigator's judgment) to wash out of current regimen.
* Estimated IQ score\~ 80 as assessed by Wechsler Intelligence Scale for Children-Fourth Edition ,WISC-IV.
* Ability to comply with all the testing and requirements.
Exclusion Criteria:
* Current, controlled (requiring a restricted medicatio n) or uncontrolled, comorbid psychiatric diagnosis , based on MINI-KID and subsequent clinical interviewing, with significant symptoms including but not limited to post-traumatic stress disorder , psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder , conduct disorder , or other symptomatic manifestatio ns that in the opinion of the Investigator may confound study data/assessments .
* Children who are currently at risk of suicide or have attempted suicide; children who have a history of suicide or are currently exhibiting active suicidal ideation or self-harm.
* Unable to stop taking ADHD medication.
* Motor condition (e.g., physical deformity of the hands/arms ; prostheses) that prevents playing the digital therapy as reported by the parent or observed by the investigator .
* Recent history (within the past 6 months) of suspected substance abuse or dependence.
* History of seizures (exclusive of febr ile seizures) , or significant motor or vocal tics, including but not limited to Tourette 's Disorder.
* Diagnosis of or parent-reported color blindness.
* Uncorrected visual acuity (Confirmed in-clinic via ability of subject to play the game).
* With severe mental retardation.
* Any other medical condition that in the opinion of the investigato r may confound study data/assessments.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
12 Years
Study:
NCT05435651
Study Brief:
Protocol Section:
NCT05435651