Trial record 1 of 1 for:    akili AND adhd
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Cognitive ADHD Videogame Exploratory Study (CAVES)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Akili Interactive Labs, Inc.
Sponsor:
Information provided by (Responsible Party):
Akili Interactive Labs, Inc.
ClinicalTrials.gov Identifier:
NCT01943539
First received: September 5, 2013
Last updated: August 6, 2014
Last verified: August 2014
  Purpose

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


Condition Intervention
Attention Deficit Hyperactivity Disorder
Device: Neuro-typical controls and ADHD will receive EVO game play.

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Akili Interactive Labs, Inc.:

Primary Outcome Measures:
  • Demonstrate a difference in EVO cognitive measures between neuro-typicals and ADHD subjects [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    As a primary end-point, the study will aim to show a difference in cognitive measures between neuro-typicals and ADHD subjects.

  • Evaluate EVO safety [ Time Frame: Day 0 through Day 28 of the study ] [ Designated as safety issue: Yes ]
    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 29 day period of time.


Secondary Outcome Measures:
  • EVO game play feasibility [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    Demonstrate the ability of ADHD and neuro-typical children to complete EVO in-clinic diagnostic assessment (DAY 0). Demonstrate compliance (measure behavioral play patterns) of ADHD and neuro-typical children during out-patient EVO game training period (DAY 1-27). Demonstrate the ability of ADHD and neuro-typical children to complete in-clinic EVO diagnostic assessment (DAY 28).


Other Outcome Measures:
  • Exploratory objective to evaluate improvements in cognitive function [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    An exploratory objective of this study is to investigate any improvements in cognitive function, as measured by EVO and standard cognitive assessments, that result from the 27 days of game training


Estimated Enrollment: 80
Study Start Date: September 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   8 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01943539

Contacts
Contact: Scott C Kellogg, MS 617-456-0984 skellogg@akiliinteractive.com

Locations
United States, Florida
Florida Clinical Research Center, LLC Completed
Bradenton, Florida, United States, 32401
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27710
Contact: Scott H Kollins, PhD    919-681-0014    scott.kollins@duke.edu   
Principal Investigator: Scottt H Kollins, PhD         
Sponsors and Collaborators
Akili Interactive Labs, Inc.
Investigators
Principal Investigator: Andrew J Cutler, MD Florida Clinical Research Center, LLC
  More Information

No publications provided

Responsible Party: Akili Interactive Labs, Inc.
ClinicalTrials.gov Identifier: NCT01943539     History of Changes
Other Study ID Numbers: Akili-001
Study First Received: September 5, 2013
Last Updated: August 6, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Disease
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Dyskinesias
Mental Disorders
Mental Disorders Diagnosed in Childhood
Nervous System Diseases
Neurologic Manifestations
Pathologic Processes
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014