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

NCT03844269 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2023-11-14

Study results available
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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).

Conditions

  • Attention Deficit Hyperactivity Disorder

Interventions

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.

Sponsors & Collaborators

  • Akili Interactive Labs, Inc.

    lead INDUSTRY

Principal Investigators

  • Elysa J Marco, MD · Cortica Healthcare

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
8 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-10
Primary Completion
2020-02-01
Completion
2020-02-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03844269 on ClinicalTrials.gov