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 @ 11:00 PM
Ignite Modification Date:
2025-12-24 @ 11:00 PM
NCT ID:
NCT03844269
Eligibility Criteria:
Inclusion Criteria:
* Confirmed Attention Deficit Hyperactivity Disorder (ADHD) diagnosis at screening/baseline visit based on Diagnostic Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-V) criteria and established via the Mini-International Neuropsychiatric Interview for Children and Adolescents (MINI-KID) administered by a trained clinician either in person or via teleconference
* Wechsler Intelligence Scale for Children 5th Edition (WISC-V), Full Scale Intelligence Quotient ≥ 70
* Vanderbilt ADHD Diagnostic Parent Rating Scale: Must score a 2 or 3 on at least 6 items 1-9 AND must score a 4 on at least 2, or 5 on at least 1, of items 48-54 (performance questions).
* Consistently off stimulant medication for ≥ 1 week. OR currently on stimulant medication and agree to stop taking the medication for a 1 week prior to the baseline visit and off through duration of training and post-training assessment (note: participants will only be allowed to washout of stimulant medication if in the opinion of the investigator they are currently inadequately managed on their medication and it is appropriate to stop taking their medication for the duration of the trial)
* Consistently off Psychotropic drug for ≥ 1 month
* Consistently off non-stimulant medication for ADHD (e.g. atomoxetine, clonidine, guanfacine) for ≥ 1 month
* Able to follow written and verbal instructions (English) as assessed by the PI and/or study coordinator
* Functioning at an age-appropriate level intellectually
* Able to comply with all testing and requirements
Exclusion Criteria:
* Current controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis, based on the Neurodevelopment Intake Form, Behavior Assessment System for Children (BASC), and subsequent clinical interviewing, with significant symptoms including but not limited to post-traumatic stress disorder, psychosis, bipolar illness, severe obsessive compulsive disorder, severe depressive or anxiety disorder, conduct disorder, or other symptomatic manifestations that in the opinion of the Investigator may confound study data/assessments. (Participants with clinical history of learning disorders will be allowed to participate as long as the disorder does not impact their ability to participate based on PI judgement).
* Autism Spectrum Disorder concern as indicated from the Social Communication Questionnaire ≥ 15.
* Current treatment with stimulant treatment for ADHD and unwilling or inappropriate (per investigator opinion) to washout.
* Initiation or completion of behavioral therapy within the last 4 weeks. The participant should inform the Investigator if they intend to change their behavioral therapy during the 4 weeks of the study. Participants who have been in behavior therapy consistently for more than 4 weeks may participate if their routine is unchanged throughout the study.
* Participant is currently considered at risk for attempting suicide by the Investigator, has previously made a suicide attempt, or has a prior history of, or is currently demonstrating active suicidal ideation or self-injurious behavior, as measured by MINI-KID Suicidality Module C.
* Motor condition (e.g. physical deformity of the hands/arms) that prevents game playing as reported by the parent or observed by the Investigator.
* Recent history or suspicion (within the past 6 months) of substance abuse or dependence.
* History of seizures (excluding febrile seizures).
* Participation in a clinical trial within 90 days prior to screening.
* Color blindness as detected by Ishihara Color Blindness Test.
* Regular use of psychoactive drugs that in the opinion of the Investigator may confound study data/assessments.
* Any other medical condition that in the opinion of the Investigator may confound study data/assessments.
* Previously received AKL-T01 (Project-EVO™) treatment in a previous clinical trial.
* Concurrent brain training
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
12 Years
Study:
NCT03844269
Study Brief:
Protocol Section:
NCT03844269