Cognitive ADHD Videogame Exploratory Study

NCT01943539 | Completed Results

• 1 other identifier: Akili-001
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Time Spent Completing the Intervention

  28 days

Other Outcomes (1)

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

  Day 0 and Day 28

Study Arms (1)

EVO Game Play

EXPERIMENTAL

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

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

Interventions

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

EVO mobile video application

EVO Game Play

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Akili Interactive Labs, Inc.: lead

Study Sites (2)

Florida Clinical Research Center, LLC

Bradenton, Florida, 32401, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

• 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.

  PMID: 29324745 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: SVP of Medical Devices
• Organization: Akili Interactive Labs

skellogg@akiliinteractive.com

617-456-0984

Study Officials

• Andrew J Cutler, MD

  Florida Clinical Research Center, LLC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2013
• First Posted: September 17, 2013
• Study Start: September 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: December 13, 2017
• Results First Posted: December 13, 2017

Record last verified: 2017-11

Locations

US (2)