Cognitive ADHD Videogame Exploratory Study (CAVES)
|Attention Deficit Hyperactivity Disorder||Device: Neuro-typical controls and ADHD will receive EVO game play.|
|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|
- Demonstrate a difference in EVO cognitive measures between neuro-typicals and ADHD subjects [ Time Frame: Up to 12 months ]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 ]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.
- EVO game play feasibility [ Time Frame: Up to 12 months ]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).
- Exploratory objective to evaluate improvements in cognitive function [ Time Frame: Up to 12 months ]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
|Study Start Date:||September 2013|
|Study Completion Date:||May 2015|
|Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01943539
|United States, Florida|
|Florida Clinical Research Center, LLC|
|Bradenton, Florida, United States, 32401|
|United States, North Carolina|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Andrew J Cutler, MD||Florida Clinical Research Center, LLC|