Cognitive ADHD Videogame Exploratory Study



Status:Completed
Conditions:Neurology, Psychiatric
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:8 - 12
Updated:12/15/2017
Start Date:September 2013
End Date:May 2015

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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.

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.

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.
We found this trial at
2
sites
8043 Cooper Creek Boulevard Suite 107
Bradenton, Florida 34201
(941) 747-7900
Florida Clinical Research Center, LLC Led by Andrew J. Cutler, M.D., Florida Clinical Research Center,...
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Durham, North Carolina 27710
(919) 684-8111
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Durham, NC
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