An interventional study of Neuro-typical controls and ADHD will receive EVO game play. in Attention Deficit Hyperactivity Disorder, sponsored by Akili Interactive Labs, Inc.. Completed at 2 sites in United States. Open to participants aged 8 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-12-13.
Sponsored by Akili Interactive Labs, Inc. · Not applicable, Interventional, and Treatment
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.
729 studies on the registry are indexed under Hyperkinesis; 25 are open to participants now.
This study's enrollment of 84 is close to the median of 80 across 583 interventional studies indexed under Hyperkinesis.
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Exclusion Criteria:
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
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.
Time frame: 28 days
Number of Participants With Non-Treatment Related Adverse Events
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 frame: Day 0 through Day 28 of the study
Time Spent Completing the Intervention
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).
Time frame: 28 days
Mean of Differences in TOVA Attention Performance Index (API) at Baseline (Day 0) and at 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.
Time frame: Day 0 and Day 28
| Milestone | Neuro-typical Controls | ADHD |
|---|---|---|
| Started | 44 | 40 |
| Completed | 40 | 40 |
| Not completed | 4 | 0 |
| Withdrew: Non-compliance with at-home intervention | 4 | 0 |
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.
| Reaction time (ms) | EVO Game Play |
|---|---|
| ADHD | 520 ± 0.091 |
| Neuro-typical | 480 ± 0.052 |
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.
| Participants | EVO Game Play |
|---|---|
| ADHD (non-treatment related AEs) | 4 |
| Neuro-typical (non-treatment related AEs) | 5 |
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).
| Hours | EVO Game Play |
|---|---|
| ADHD | 10.8 ± 2.8 |
| Neuro-typical | 11.5 ± 2.6 |
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.
| Cumulative z-score | Neurotypical Controls | ADHD |
|---|---|---|
| Mean of Differences in TOVA Attention Performance Index (API) at Baseline (Day 0) and at Day 28 | -0.39 (-1.16 to 0.37) | -1.43 (-2.75 to -0.12) |
Collected over 8 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Neurotypical Controls | 0/44 (0%) | 1/44 (2.3%) | 4/44 (9.1%) |
| ADHD | 0/40 (0%) | 0/40 (0%) | 4/40 (10%) |
| Event | Neurotypical Controls | ADHD |
|---|---|---|
| Acute reflux esophagitisGastrointestinal disorders | 1/44 | 0/40 |
| Event | Neurotypical Controls | ADHD |
|---|---|---|
| HeadacheGeneral disorders | 0/44 | 2/40 |
| ToothacheGeneral disorders | 0/44 | 1/40 |
| Viral gastroenteritisGastrointestinal disorders | 1/44 | 1/40 |
| Upper Respiratory InfectionRespiratory, thoracic and mediastinal disorders | 1/44 | 0/40 |
| Foot painGeneral disorders | 1/44 | 0/40 |
| InfluenzaInfections and infestations | 1/44 | 0/40 |
84 subjects were started, 4 subjects (neurotypical) were excluded from the analysis for non-compliance with the at-home intervention use.
| Age, Continuous(years) | EVO Game Play |
|---|---|
| ADHD | 10.35 ± 1.24 |
| Neuro-typical | 10.54 ± 1.49 |
| Sex: Female, Male(Participants) | EVO Game Play |
|---|---|
| ADHD — Female | 16 |
| ADHD — Male | 24 |
| Neuro-typical — Female | 19 |
| Neuro-typical — Male | 21 |
| Region of Enrollment(participants) | EVO Game Play |
|---|---|
| United States | 80 |
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Akili Interactive Labs, Inc.