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Cognitive ADHD Videogame Exploratory Study (CAVES)

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Neuro-typical controls and ADHD will receive EVO game play.

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder

Eligibility Criteria

8 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Age 8 to 12 at the time of parental informed consent.
Confirmed ADHD diagnosis at clinic per MINI-Kid (ADHD Cohort)
Baseline ADHD-RS-IV score >= 24 (ADHD Cohort), obtained at clinic
Baseline ADHD-RS-IV score <=13 (Neuro-typical Cohort), obtained at clinic
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
Consistently off Psychotropic drug for 1 month (Other than ADHD drug noted above)
Ability to follow written and verbal instructions (English)
Girls or Boys (Gender-matched - 30% girls minimum)
Functioning at an age-appropriate level intellectually.
Ability to comply with all the testing and requirements.

Exclusion Criteria:

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).
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.
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).
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).
Motor condition that prevents game playing
Recent history (within the past 6 months) of suspected substance abuse or dependence.
History of seizures (exclusive of febrile seizures), a tic disorder, significant tics, or a current diagnosis of Tourette's Disorder.
Taken part in a clinical trial within 30 days prior to screening.
Diagnosis of color blindness
Regular use of psychoactive drugs that in the opinion of the Investigator may confound study data/assessments.
Any other medical condition that in the opinion of the Investigator may confound study data/assessments.

Sites / Locations

Florida Clinical Research Center, LLC
Duke University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EVO Game Play

Arm Description

Neuro-typical controls and ADHD will receive EVO game play.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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).

Full Information

NCT ID

NCT01943539

First Posted

September 5, 2013

Last Updated

November 14, 2017

Sponsor

Akili Interactive Labs, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01943539

Brief Title

Cognitive ADHD Videogame Exploratory Study

Acronym

CAVES

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Completed

Study Start Date

September 2013 (undefined)

Primary Completion Date

May 2015 (Actual)

Study Completion Date

May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Akili Interactive Labs, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Attention Deficit Hyperactivity Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

84 (Actual)

8. Arms, Groups, and Interventions

Arm Title

EVO Game Play

Arm Type

Experimental

Arm Description

Neuro-typical controls and ADHD will receive EVO game play.

Intervention Type

Device

Intervention Name(s)

Neuro-typical controls and ADHD will receive EVO game play.

Intervention Description

EVO mobile video application

Primary Outcome Measure Information:

Title

Reaction Time in EVO Gameplay

Description

Time Frame

28 days

Title

Number of Participants With Non-Treatment Related Adverse Events

Description

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.

Time Frame

Day 0 through Day 28 of the study

Secondary Outcome Measure Information:

Title

Time Spent Completing the Intervention

Description

Time Frame

28 days

Other Pre-specified Outcome Measures:

Title

Mean of Differences in TOVA Attention Performance Index (API) at Baseline (Day 0) and at Day 28

Description

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.

Time Frame

Day 0 and Day 28

10. Eligibility

Sex

All

Minimum Age & Unit of Time

8 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 8 to 12 at the time of parental informed consent. Confirmed ADHD diagnosis at clinic per MINI-Kid (ADHD Cohort) Baseline ADHD-RS-IV score >= 24 (ADHD Cohort), obtained at clinic Baseline ADHD-RS-IV score <=13 (Neuro-typical Cohort), obtained at clinic 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 Consistently off Psychotropic drug for 1 month (Other than ADHD drug noted above) Ability to follow written and verbal instructions (English) Girls or Boys (Gender-matched - 30% girls minimum) Functioning at an age-appropriate level intellectually. Ability to comply with all the testing and requirements. Exclusion Criteria: 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). 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. 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). 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). Motor condition that prevents game playing Recent history (within the past 6 months) of suspected substance abuse or dependence. History of seizures (exclusive of febrile seizures), a tic disorder, significant tics, or a current diagnosis of Tourette's Disorder. Taken part in a clinical trial within 30 days prior to screening. Diagnosis of color blindness Regular use of psychoactive drugs that in the opinion of the Investigator may confound study data/assessments. Any other medical condition that in the opinion of the Investigator may confound study data/assessments.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andrew J Cutler, MD

Organizational Affiliation

Florida Clinical Research Center, LLC

Official's Role

Principal Investigator

Facility Information:

Facility Name

Florida Clinical Research Center, LLC

City

Bradenton

State/Province

Florida

ZIP/Postal Code

32401

Country

United States

Facility Name

Duke University

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

29324745

Citation

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.

Results Reference

derived

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Cognitive ADHD Videogame Exploratory Study

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