Clinical trial NCT01943539: Cognitive ADHD Videogame Exploratory Study
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
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Lead sponsor: Akili Interactive Labs, Inc.
Sponsor class: INDUSTRY
First posted: 2013-09-17
Enrollment: 84
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Reaction Time in EVO Gameplay
timeFrame: 28 days
measure: Number of Participants With Non-Treatment Related Adverse Events
timeFrame: Day 0 through Day 28 of the study
Secondary outcomes:
measure: Time Spent Completing the Intervention
timeFrame: 28 days
Other outcomes:
measure: Mean of Differences in TOVA Attention Performance Index (API) at Baseline (Day 0) and at Day 28
timeFrame: Day 0 and Day 28
Locations:
city: Bradenton
country: United States
facility: Florida Clinical Research Center, LLC
state: Florida
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Florida Clinical Research Center, LLC
name: Andrew J Cutler, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.