Software Treatment for Actively Reducing Severity of ADHD as Adjunctive Treatment to Stimulant
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effects of combining AKL-T01 (with AKL-X01
      symptom tracking) as adjunctive treatment to stimulant medication, and to understand the
      effects of AKL-T01 treatment (with AKL-X01 symptom tracking) in participants not recently on
      medication.
    

Detailed description: 
      The study aims to enroll (203) participants, with a confirmed diagnoses of ADHD, at
      approximately 15 sites and will be divided between 2 cohorts; 130 participants will be
      enrolled in Cohort 1, and 73 participants will be enrolled in Cohort 2.

      Cohort 1 will have been stable (adherence to a prescribed medication schedule) on a stimulant
      medication, but are inadequately managed by the stimulant (in the opinion of the
      investigator). The stimulant is managed by their own physician for at least 30 days before
      baseline. This is the Stimulant cohort.

      Cohort 2 will have been stable without any stimulant medication for at least 30 days before
      the baseline. This is the Non-Stimulant cohort.

      For both cohorts, at least 7 and up to 30 days before baseline, participants' caretakers will
      begin using AKL-X01 (Fengo) to track their participants' symptoms and behaviors.

      During Treatment Phase 1 (Days 1 through 28) participants in Cohort 1 (Stimulant) will
      continue to receive their current stimulant plus the addition of AKL-T01. Participants in
      Cohort 2 (Non-Stimulant) will just receive AKL-T01. For both cohorts, during this time the
      caretakers will monitor their child's symptoms daily with AKL-X01.

      During the 1-Month Break (Days 29 through 56) between AKL-T01 treatment phases, participants
      in Cohort 1 will continue to receive their current stimulant. In both cohorts, AKL-T01 will
      be suspended during this time. For both cohorts, during this time caretakers will continue to
      monitor their child's symptoms daily with AKL-X01.

      During Treatment Phase 2 (Days 57 through 84), participants in Cohort 1 (stimulant) will
      continue to receive their current stimulant plus the addition of AKL-T01. Participants in
      Cohort 2 will just receive AKL-T01. For both cohorts, during this time the caretakers will
      monitor their child's symptoms daily with AKL-X01.

      AKL-T01, or EVO Multi, is a digital intervention that requires the subject to navigate a
      character through a game-like space, while collecting objects, in a fixed period of time.

      AKL-T01: Videogame-like digital therapy
    

Intervention name(s): AKL-T01
Intervention type(s): Device
Intervention description(s): AKL-T01 multitasking digital treatment. AKL-T01 multitasking treatment employs perceptual discrimination attention/memory task as well as a continuous motor "driving" task.
Intervention model: Single Group Assignment
Intervention model description: The study will enroll participants into one of two cohorts according to stimulant status. Both cohorts will be assigned to AKL-T01 (with AKL-X01 symptom tracking).
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ADHD