Cognitive ADHD Videogame Exploratory Study (CAVES)
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|ClinicalTrials.gov Identifier: NCT01943539|
Recruitment Status : Completed
First Posted : September 17, 2013
Results First Posted : December 13, 2017
Last Update Posted : December 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Attention Deficit Hyperactivity Disorder||Device: Neuro-typical controls and ADHD will receive EVO game play.||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||84 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||September 2013|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||May 2015|
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
- Reaction Time in EVO Gameplay [ Time Frame: 28 days ]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.
- Number of Participants With Non-Treatment Related Adverse Events [ 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 28-day period of time.
- Time Spent Completing the Intervention [ Time Frame: 28 days ]Time spent on completing the intervention is based on the prescribed therapy of 800 total minutes, or 13.3 hours, over the course of 28 days (7 sessions of EVO per day for 5 days per week for 4 weeks with each session lasting approximately 5.7 minutes long).
- Mean of Differences in TOVA Attention Performance Index (API) at Baseline (Day 0) and at Day 28 [ Time Frame: Day 0 and Day 28 ]
TOVA API is a comparison of the subject's scores based on selected measures that persons with an independent diagnosis of ADHD frequently demonstrated. The API is calculated from variability, response time, and D' (D Prime) using the following formula:
API = Response Time Z score (Half 1) + D' Z score (Half 2) + Variability Z score (Total) + 1.80
where Response Time is the average time it takes to respond correctly to a target, d' (D Prime) score is a response discriminability score reflecting the ratio of hits to "false alarms", and Variability is a measure of consistency of speed of responding based on the standard deviation of the mean correct response times. API tells how similar the score is to the ADHD profile. A score of less than -1.8 indicates that the subject had similar performance to a normative ADHD population. A lower score indicates a more severe ADHD profile.
The calculation for difference in TOVA API was API at Baseline (Day 0) minus API at Day 28.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|