At a glance
ClinicalIndex Comparison Record- ✓Confirmed ADHD diagnosis per DSM-V criteria verified by MINI-KID administered by trained clinician
- ✓Full Scale IQ ≥70 on WISC-V
- ✓Vanderbilt ADHD Diagnostic Parent Rating Scale: score 2-3 on at least 6 items (1-9) AND score 4 on at least 2 OR score 5 on at least 1 of items (48-54)
- ✓Either consistently off stimulant medication ≥1 week OR willing to washout for 1 week before baseline through post-training assessment if investigator deems medication inadequate
- ✕Current or uncontrolled comorbid psychiatric diagnoses with significant symptoms (PTSD, psychosis, bipolar disorder, severe OCD, severe depression/anxiety, conduct disorder) that may confound study data
- ✕Autism Spectrum Disorder concern (Social Communication Questionnaire ≥15)
- ✕Current stimulant treatment for ADHD if unwilling or inappropriate to washout per investigator
- ✕Initiation or completion of behavioral therapy within last 4 weeks; intention to change therapy during 4-week study
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Study to Assess Midline Frontal Theta (MFT) Power as Measured by Stimulus-locked Electroencephalography (EEG) Before and After AKL-T01 Treatment for Improving Attention in Pediatric Participants Ages 8-12 Years Old With Attention Deficit Hyperactivity Disorder (ADHD)
In Brief
A clinical study evaluating AKL-T01 for Attention Deficit Hyperactivity Disorder. Completed, enrolled 28 participants across 1 site.
Detailed 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).
Study Details
Timeline
Interventions
AKL-T01 digital treatment is a state-of-the-art mobile video game-like platform, which deploys modern videogame graphics, engaging reward loops, and real-time adaptive mechanics to dynamically personalize difficulty based on the user's ability. AKL-T01 multitasking treatment employs perceptual discrimination attention/memory task as well as a continuous motor "driving" task. Performance on these tasks are assessed in isolation and when performed together to calculate a performance index for each individual user. A personalized multitask treatment regimen is automatically configured and delivered to the user and is optimized adaptively to increase multitask performance. As players proceed through the treatment periodic recalibration occurs to maintain an optimal difficulty level.