NCT03844269

Electroencephalogram (EEG) Study of Inattention Following Treatment With AKL-T01

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Akili Interactive Labs, Inc. · Industry
• Sex: All
• Age: 8 Years – 12 Years
• Healthy volunteers: Not accepted

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).

Detailed description

All participants enrolled in this study will not be taking medications for attention deficit hyperactivity disorder (ADHD), including stimulants, for the duration of the study. Participants who are taking ADHD medications prior to Day 0 must have been stable off of medications for at least 30 days per parent report, or washout of medications at a Screening visit 3 - 7 days prior to Day 0. At Baseline / Day 0, all eligible participants will complete both resting-state electroencephalogram (EEG) and a perceptual discrimination task (PDT)-locked EEG. All participants will then play AKL-T01 for approximately 25 minutes per day, 5 days per week, for 4 weeks at home. At Follow-up / Day 28, participants will repeat both resting-state and PDT-locked EEG.

Conditions

• Attention Deficit Hyperactivity Disorder

Interventions

Type	Name	Description
DEVICE	AKL-T01	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.

Timeline

• Start date: 2019-05-10
• Primary completion: 2020-02-01
• Completion: 2020-02-01
• First posted: 2019-02-18
• Last updated: 2023-11-14
• Results posted: 2023-11-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study