Attention Deficit Hyperactivity Disorder
Conditions
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.
Interventions
DEVICENeuro-typical controls and ADHD will receive EVO game play.
EVO mobile video application
Sponsors
Akili Interactive Labs, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 12 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reaction Time in EVO Gameplay | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time Spent Completing the Intervention | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mean of Differences in TOVA Attention Performance Index (API) at Baseline (Day 0) and at Day 28 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| EVO Game Play Neuro-typical controls and ADHD will receive EVO game play.
Neuro-typical controls and ADHD will receive EVO game play.: EVO mobile video application | 80 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Non-compliance with at-home intervention | 4 | 0 |
Baseline characteristics
| Characteristic | EVO Game Play |
|---|---|
| Age, Continuous ADHD | 10.35 years STANDARD_DEVIATION 1.24 |
| Age, Continuous Neuro-typical | 10.54 years STANDARD_DEVIATION 1.49 |
| Region of Enrollment United States | 80 participants |
| Sex: Female, Male ADHD Female | 16 Participants |
| Sex: Female, Male ADHD Male | 24 Participants |
| Sex: Female, Male Neuro-typical Female | 19 Participants |
| Sex: Female, Male Neuro-typical Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 44 | 0 / 40 |
| other Total, other adverse events | 4 / 44 | 4 / 40 |
| serious Total, serious adverse events | 1 / 44 | 0 / 40 |
Outcome results
Primary
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
Population: All subjects completing 4 weeks of at-home play and returning to the clinic on DAY 28.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EVO Game Play | Number of Participants With Non-Treatment Related Adverse Events | ADHD (non-treatment related AEs) | 4 Participants |
| EVO Game Play | Number of Participants With Non-Treatment Related Adverse Events | Neuro-typical (non-treatment related AEs) | 5 Participants |
Primary
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
Population: All subjects completing 4 weeks of at-home play and returning to the clinic on DAY 28.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EVO Game Play | Reaction Time in EVO Gameplay | ADHD | 520 Reaction time (ms) | Standard Deviation 0.091 |
| EVO Game Play | Reaction Time in EVO Gameplay | Neuro-typical | 480 Reaction time (ms) | Standard Deviation 0.052 |
p-value: 0.008t-test, 2 sided
Secondary
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
Population: All subjects completing 4 weeks of at-home play and returning to the clinic on DAY 28.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EVO Game Play | Time Spent Completing the Intervention | ADHD | 10.8 Hours | Standard Deviation 2.8 |
| EVO Game Play | Time Spent Completing the Intervention | Neuro-typical | 11.5 Hours | Standard Deviation 2.6 |
Other Pre-specified
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
Population: All subjects completing 4 weeks of at-home play and returning to the clinic on DAY 28.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| EVO Game Play | Mean of Differences in TOVA Attention Performance Index (API) at Baseline (Day 0) and at Day 28 | -0.39 Cumulative z-score |
| ADHD | Mean of Differences in TOVA Attention Performance Index (API) at Baseline (Day 0) and at Day 28 | -1.43 Cumulative z-score |