Clinical trial NCT03844269: Electroencephalogram (EEG) Study of Inattention Following Treatment With AKL-T01
Official title: A Study to Assess Midline Frontal Theta (MFT) Power as Measured by Stimulus-locked Electroencephalography (EEG) Before and After AKL-T01 Treatment for Improving Attention in Pediatric Participants Ages 8-12 Years Old With Attention Deficit Hyperactivity Disorder (ADHD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: ADHD
Inattention
Lead sponsor: Akili Interactive Labs, Inc.
Sponsor class: INDUSTRY
First posted: 2019-02-18
Enrollment: 28
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Intervention group will be compared to historical controls.
Primary purpose: TREATMENT

Brief summary: This study is a single arm, open-label, pilot study to assess midline frontal theta (MFT) power as measured by stimulus-locked electroencephalogram (EEG) before and after treatment with AKL-T01 for improving attention in pediatric participants ages 8-12 years old with attention deficit hyperactivity disorder (ADHD).

Detailed description: All participants enrolled in this study will not be taking medications for attention deficit hyperactivity disorder (ADHD), including stimulants, for the duration of the study. Participants who are taking ADHD medications prior to Day 0 must have been stable off of medications for at least 30 days per parent report, or washout of medications at a Screening visit 3 - 7 days prior to Day 0.

At Baseline / Day 0, all eligible participants will complete both resting-state electroencephalogram (EEG) and a perceptual discrimination task (PDT)-locked EEG.

All participants will then play AKL-T01 for approximately 25 minutes per day, 5 days per week, for 4 weeks at home.

At Follow-up / Day 28, participants will repeat both resting-state and PDT-locked EEG.

Eligibility criteria: Inclusion Criteria:

* Confirmed Attention Deficit Hyperactivity Disorder (ADHD) diagnosis at screening/baseline visit based on Diagnostic Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-V) criteria and established via the Mini-International Neuropsychiatric Interview for Children and Adolescents (MINI-KID) administered by a trained clinician either in person or via teleconference
* Wechsler Intelligence Scale for Children 5th Edition (WISC-V), Full Scale Intelligence Quotient ≥ 70
* Vanderbilt ADHD Diagnostic Parent Rating Scale: Must score a 2 or 3 on at least 6 items 1-9 AND must score a 4 on at least 2, or 5 on at least 1, of items 48-54 (performance questions).
* Consistently off stimulant medication for ≥ 1 week. OR currently on stimulant medication and agree to stop taking the medication for a 1 week prior to the baseline visit and off through duration of training and post-training assessment (note: participants will only be allowed to washout of stimulant medication if in the opinion of the investigator they are currently inadequately managed on their medication and it is appropriate to stop taking their medication for the duration of the trial)
* Consistently off Psychotropic drug for ≥ 1 month
* Consistently off non-stimulant medication for ADHD (e.g. atomoxetine, clonidine, guanfacine) for ≥ 1 month
* Able to follow written and verbal instructions (English) as assessed by the PI and/or study coordinator
* Functioning at an age-appropriate level intellectually
* Able to comply with all testing and requirements

Exclusion Criteria:

* Current controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis, based on the Neurodevelopment Intake Form, Behavior Assessment System for Children (BASC), and subsequent clinical interviewing, with significant symptoms including but not limited to post-traumatic stress disorder, psychosis, bipolar illness, severe obsessive compulsive disorder, severe depressive or anxiety disorder, conduct disorder, or other symptomatic manifestations that in the opinion of the Investigator may confound study data/assessments. (Participants with clinical history of learning disorders will be allowed to participate as long as the disorder does not impact their ability to participate based on PI judgement).
* Autism Spectrum Disorder concern as indicated from the Social Communication Questionnaire ≥ 15.
* Current treatment with stimulant treatment for ADHD and unwilling or inappropriate (per investigator opinion) to washout.
* Initiation or completion of behavioral therapy within the last 4 weeks. The participant should inform the Investigator if they intend to change their behavioral therapy during the 4 weeks of the study. Participants who have been in behavior therapy consistently for more than 4 weeks may participate if their routine is unchanged throughout the study.
* Participant is currently considered at risk for attempting suicide by 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, as measured by MINI-KID Suicidality Module C.
* Motor condition (e.g. physical deformity of the hands/arms) that prevents game playing as reported by the parent or observed by the Investigator.
* Recent history or suspicion (within the past 6 months) of substance abuse or dependence.
* History of seizures (excluding febrile seizures).
* Participation in a clinical trial within 90 days prior to screening.
* Color blindness as detected by Ishihara Color Blindness Test.
* Regular use of psychoactive drugs that in the opinion of the Investigator may confound study data/assessments.
* Any other medical condition that in the opinion of the Investigator may confound study data/assessments.
* Previously received AKL-T01 (Project-EVO™) treatment in a previous clinical trial.
* Concurrent brain training

Primary outcomes:
measure: Midline Frontal Theta Power (MFT)
timeFrame: Day 0 to Day 28
Secondary outcomes:
measure: Midline Frontal Theta Power (MFT)
timeFrame: Day 28
Other outcomes:
Locations:
city: San Rafael
country: United States
facility: Cortica Healthcare
state: California
Study officials:
affiliation: Cortica Healthcare
name: Elysa J Marco, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gallen CL, Anguera JA, Gerdes MR, Simon AJ, Canadas E, Marco EJ. Enhancing neural markers of attention in children with ADHD using a digital therapeutic. PLoS One. 2021 Dec 31;16(12):e0261981. doi: 10.1371/journal.pone.0261981. eCollection 2021.