Cognitive ADHD Videogame Exploratory Study (CAVES)

A Study to Assess the Feasibility of EVO Gameplay to Engage Children With Attention Deficit Hyperactivity Disorder (ADHD) and to Evaluate Cognitive Interference in Children Ages 8 to 12 Years Old With ADHD Compared to Neuro-typical Children

A study in ADHD and neuro-typical children to assess EVO game play over 29 days.

Study Overview

• Status: Completed
• Conditions: Attention Deficit Hyperactivity Disorder
• Intervention / Treatment: Device: Neuro-typical controls and ADHD will receive EVO game play.

Detailed Description

A study in children ages 8 to 12 to assess EVO cognitive game play. The study examines two populations, children diagnosed with ADHD (ADHD and not on medication) and neuro-typical children. The investigators plan to evaluate 80 subjects (N = 40 per group) in three site locations over a 29 day study period. The 29 day study period includes 2 in-clinic sessions and 27 days of out-patient game play. During the 27 days of out-patient game play, the subjects will be instructed to play EVO 5 days per week for typically 30 minutes per day

The investigators' hypothesis is that EVO will be playable and interesting to ADHD children and cognitive measures, as captured by EVO, will show a difference between ADHD children and age-matched neuro-typical children.

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Bradenton, Florida, United States, 32401
      • Florida Clinical Research Center, LLC
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age 8 to 12 at the time of parental informed consent.
2. Confirmed ADHD diagnosis at clinic per MINI-Kid (ADHD Cohort)
3. Baseline ADHD-RS-IV score >= 24 (ADHD Cohort), obtained at clinic
4. Baseline ADHD-RS-IV score <=13 (Neuro-typical Cohort), obtained at clinic
5. Consistently off ADHD drug for 1 week. Drugs include: Pre specified, oral psychostimulants (ADDERALL XR® [mixed salts of a single-entity amphetamine product], VYVANSE® [lisdexamfetamine dimesylate], CONCERTA® [methylphenidate HCl], FOCALIN XR® [dexmethylphenidate HCl], RITALIN LA® [methylphenidate HCl extended-release], METADATE CD® [methylphenidate HCl, USP], or FDA-approved generic equivalents )for 1 month (Other than ADHD drud
6. Consistently off Psychotropic drug for 1 month (Other than ADHD drug noted above)
7. Ability to follow written and verbal instructions (English)
8. Girls or Boys (Gender-matched - 30% girls minimum)
9. Functioning at an age-appropriate level intellectually.
10. Ability to comply with all the testing and requirements.

Exclusion Criteria:

1. Current, controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as post-traumatic stress disorder, psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder, conduct disorder, or other symptomatic manifestations that in the opinion of the Investigator that may confound study data/assessments (per MINI-Kid).
2. Within the last 4 weeks, subject has entered or exited behavioral therapy. The subject should inform the Investigator if they intend to change their behavioral therapy during the 4 weeks of the study.
3. Subject is currently considered a suicide risk in the opinion of the Investigator, has previously made a suicide attempt, or has a prior history of, or is currently demonstrating active suicidal ideation or self-injurious behavior (per C-SSRS).
4. History of failure to respond to an adequate trial of 2 treatments for ADHD (consisting of an appropriate dose and adequate duration of therapy and failure in efficacy in the opinion of the Investigator).
5. Motor condition that prevents game playing
6. Recent history (within the past 6 months) of suspected substance abuse or dependence.
7. History of seizures (exclusive of febrile seizures), a tic disorder, significant tics, or a current diagnosis of Tourette's Disorder.
8. Taken part in a clinical trial within 30 days prior to screening.
9. Diagnosis of color blindness
10. Regular use of psychoactive drugs that in the opinion of the Investigator may confound study data/assessments.
11. Any other medical condition that in the opinion of the Investigator may confound study data/assessments.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EVO Game Play; Neuro-typical controls and ADHD will receive EVO game play.	Device: Neuro-typical controls and ADHD will receive EVO game play.; EVO mobile video application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reaction Time in EVO Gameplay	EVO employs a perceptual discrimination attention/memory task as well as a continuous visuomotor "driving" task. Subjects were instructed to target a pre-specified stimulus, and ignore all other stimuli while navigating a road-like course. Reaction time was measured as the time between the initial presentation of the pre-specified target and when the subject tapped the tablet screen. Longer reaction times indicated a larger deficit in multitasking.	28 days
Number of Participants With Non-Treatment Related Adverse Events	Another objective of this study is to evaluate the safety of EVO game play based on treatment-emergent adverse events (TEAEs) that may occur during this 28-day period of time.	Day 0 through Day 28 of the study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time Spent Completing the Intervention	Time spent on completing the intervention is based on the prescribed therapy of 800 total minutes, or 13.3 hours, over the course of 28 days (7 sessions of EVO per day for 5 days per week for 4 weeks with each session lasting approximately 5.7 minutes long).	28 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean of Differences in TOVA Attention Performance Index (API) at Baseline (Day 0) and at Day 28	TOVA API is a comparison of the subject's scores based on selected measures that persons with an independent diagnosis of ADHD frequently demonstrated. The API is calculated from variability, response time, and D' (D Prime) using the following formula: API = Response Time Z score (Half 1) + D' Z score (Half 2) + Variability Z score (Total) + 1.80 where Response Time is the average time it takes to respond correctly to a target, d' (D Prime) score is a response discriminability score reflecting the ratio of hits to "false alarms", and Variability is a measure of consistency of speed of responding based on the standard deviation of the mean correct response times. API tells how similar the score is to the ADHD profile. A score of less than -1.8 indicates that the subject had similar performance to a normative ADHD population. A lower score indicates a more severe ADHD profile. The calculation for difference in TOVA API was API at Baseline (Day 0) minus API at Day 28.	Day 0 and Day 28

Collaborators and Investigators

• Sponsor: Akili Interactive Labs, Inc.
• Investigators: Principal Investigator: Andrew J Cutler, MD, Florida Clinical Research Center, LLC

Publications and helpful links

General Publications

• Davis NO, Bower J, Kollins SH. Proof-of-concept study of an at-home, engaging, digital intervention for pediatric ADHD. PLoS One. 2018 Jan 11;13(1):e0189749. doi: 10.1371/journal.pone.0189749. eCollection 2018.

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: September 5, 2013
• First Submitted That Met QC Criteria: September 12, 2013
• First Posted (Estimate): September 17, 2013

Study Record Updates

• Last Update Posted (Actual): December 13, 2017
• Last Update Submitted That Met QC Criteria: November 14, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Hyperkinesis
• Other Study ID Numbers: Akili-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No