Electroencephalogram (EEG) Study of Inattention Following Treatment With AKL-T01 (NCT03844269) | Clinical Trial Compass
CompletedNot Applicable
Electroencephalogram (EEG) Study of Inattention Following Treatment With AKL-T01
United States28 participantsStarted 2019-05-10
Plain-language summary
This study is a single arm, open-label, pilot study to assess midline frontal theta (MFT) power as measured by stimulus-locked electroencephalogram (EEG) before and after treatment with AKL-T01 for improving attention in pediatric participants ages 8-12 years old with attention deficit hyperactivity disorder (ADHD).
Who can participate
Age range8 Years – 12 Years
SexALL
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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 lev…