Trial Outcomes & Findings for Cognitive ADHD Videogame Exploratory Study (NCT NCT01943539)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

84 participants

Primary outcome timeframe

28 days

Results posted on

2017-12-13

Participant Flow

Participant milestones

Participant milestones
Measure	Neuro-typical Controls Non-ADHD neuro-typical children	ADHD Children diagnosed with ADHD and not on ADHD medication.
Overall Study STARTED	44	40
Overall Study COMPLETED	40	40
Overall Study NOT COMPLETED	4	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Neuro-typical Controls Non-ADHD neuro-typical children	ADHD Children diagnosed with ADHD and not on ADHD medication.
Overall Study Non-compliance with at-home intervention	4	0

Baseline Characteristics

40 participants were analyzed in both the ADHD and neuro-typical arms.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	EVO Game Play n=80 Participants Neuro-typical controls and ADHD will receive EVO game play. Neuro-typical controls and ADHD will receive EVO game play.: EVO mobile video application
Age, Continuous ADHD	10.35 years STANDARD_DEVIATION 1.24 • n=40 Participants • 40 participants were analyzed in both the ADHD and neuro-typical arms.
Age, Continuous Neuro-typical	10.54 years STANDARD_DEVIATION 1.49 • n=40 Participants • 40 participants were analyzed in both the ADHD and neuro-typical arms.
Sex: Female, Male ADHD · Female	16 Participants n=40 Participants • Measure Analysis Population Description: 40 participants were analyzed in both the ADHD and neuro-typical arms.
Sex: Female, Male ADHD · Male	24 Participants n=40 Participants • Measure Analysis Population Description: 40 participants were analyzed in both the ADHD and neuro-typical arms.
Sex: Female, Male Neuro-typical · Female	19 Participants n=40 Participants • Measure Analysis Population Description: 40 participants were analyzed in both the ADHD and neuro-typical arms.
Sex: Female, Male Neuro-typical · Male	21 Participants n=40 Participants • Measure Analysis Population Description: 40 participants were analyzed in both the ADHD and neuro-typical arms.
Region of Enrollment United States	80 participants n=80 Participants

PRIMARY outcome

Timeframe: 28 days

Population: All subjects completing 4 weeks of at-home play and returning to the clinic on DAY 28.

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.

Outcome measures

Outcome measures
Measure	EVO Game Play n=80 Participants Neuro-typical controls and ADHD will receive EVO game play. Neuro-typical controls and ADHD will receive EVO game play.: EVO mobile video application	ADHD Children diagnosed with ADHD and not taking ADHD medication
Reaction Time in EVO Gameplay ADHD	520 Reaction time (ms) Standard Deviation 0.091	—
Reaction Time in EVO Gameplay Neuro-typical	480 Reaction time (ms) Standard Deviation 0.052	—

PRIMARY outcome

Timeframe: Day 0 through Day 28 of the study

Population: All subjects completing 4 weeks of at-home play and returning to the clinic on DAY 28.

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.

Outcome measures

Outcome measures
Measure	EVO Game Play n=80 Participants Neuro-typical controls and ADHD will receive EVO game play. Neuro-typical controls and ADHD will receive EVO game play.: EVO mobile video application	ADHD Children diagnosed with ADHD and not taking ADHD medication
Number of Participants With Non-Treatment Related Adverse Events ADHD (non-treatment related AEs)	4 Participants	—
Number of Participants With Non-Treatment Related Adverse Events Neuro-typical (non-treatment related AEs)	5 Participants	—

SECONDARY outcome

Timeframe: 28 days

Population: All subjects completing 4 weeks of at-home play and returning to the clinic on DAY 28.

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).

Outcome measures

Outcome measures
Measure	EVO Game Play n=80 Participants Neuro-typical controls and ADHD will receive EVO game play. Neuro-typical controls and ADHD will receive EVO game play.: EVO mobile video application	ADHD Children diagnosed with ADHD and not taking ADHD medication
Time Spent Completing the Intervention ADHD	10.8 Hours Standard Deviation 2.8	—
Time Spent Completing the Intervention Neuro-typical	11.5 Hours Standard Deviation 2.6	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0 and Day 28

Population: All subjects completing 4 weeks of at-home play and returning to the clinic on 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.

Outcome measures

Outcome measures
Measure	EVO Game Play n=40 Participants Neuro-typical controls and ADHD will receive EVO game play. Neuro-typical controls and ADHD will receive EVO game play.: EVO mobile video application	ADHD n=40 Participants Children diagnosed with ADHD and not taking ADHD medication
Mean of Differences in TOVA Attention Performance Index (API) at Baseline (Day 0) and at Day 28	-0.39 Cumulative z-score Interval -1.16 to 0.37	-1.43 Cumulative z-score Interval -2.75 to -0.12

Adverse Events

Neurotypical Controls

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

ADHD

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Neurotypical Controls n=44 participants at risk Non-ADHD neurotypical children	ADHD n=40 participants at risk Children diagnosed with ADHD and no on ADHD medication
Gastrointestinal disorders Acute reflux esophagitis	2.3% 1/44 • Number of events 1 • 8 months	0.00% 0/40 • 8 months

Other adverse events

Other adverse events
Measure	Neurotypical Controls n=44 participants at risk Non-ADHD neurotypical children	ADHD n=40 participants at risk Children diagnosed with ADHD and no on ADHD medication
General disorders Toothache	0.00% 0/44 • 8 months	2.5% 1/40 • Number of events 1 • 8 months
General disorders Headache	0.00% 0/44 • 8 months	5.0% 2/40 • Number of events 2 • 8 months
Gastrointestinal disorders Viral gastroenteritis	2.3% 1/44 • Number of events 1 • 8 months	2.5% 1/40 • Number of events 1 • 8 months
Respiratory, thoracic and mediastinal disorders Upper Respiratory Infection	2.3% 1/44 • Number of events 1 • 8 months	0.00% 0/40 • 8 months
General disorders Foot pain	2.3% 1/44 • Number of events 1 • 8 months	0.00% 0/40 • 8 months
Infections and infestations Influenza	2.3% 1/44 • Number of events 1 • 8 months	0.00% 0/40 • 8 months

Additional Information

SVP of Medical Devices

Akili Interactive Labs

Phone: 617-456-0984

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place