Attention Deficit Hyperactivity DisorderNCT03844269
Electroencephalogram (EEG) Study of Inattention Following Treatment With AKL-T01
A study testing AKL-T01 in people with Attention Deficit Hyperactivity Disorder, run by Akili Interactive Labs, Inc. at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- AKL-T01
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2019to 1 Feb 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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).
Read the 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.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- AKL-T01
- Keywords
- ADHD, Inattention
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AKL-T01Device
AKL-T01 digital treatment is a state-of-the-art mobile video game-like platform, which deploys modern videogame graphics, engaging reward loops, and real-time adaptive mechanics to dynamically personalize difficulty based on the user's ability. AKL-T01 multitasking treatment employs perceptual discrimination attention/memory task as well as a continuous motor "driving" task. Performance on these tasks are assessed in isolation and when performed together to calculate a performance index for each individual user. A personalized multitask treatment regimen is automatically configured and delivered to the user and is optimized adaptively to increase multitask performance. As players proceed through the treatment periodic recalibration occurs to maintain an optimal difficulty level.
| Study group | Role | What they receive |
|---|---|---|
| AKL-T01 | Experimental | Not described Receives: Device: AKL-T01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Midline Frontal Theta Power (MFT)
Change in midline frontal theta (MFT) power as measured by Perceptual Discrimination Task (PDT)-Locked Electroencephalogram (EEG).
Measured: Day 0 to Day 28
Secondary outcomes (1)
Midline Frontal Theta Power (MFT)
MFT power as measured by Perceptual Discrimination Task (PDT)-Locked Electroencephalogram (EEG) of ADHD cohort post-treatment with AKL-T01 compared to that of neurotypical cohort at Day 0 (historical controls).
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study start10 May 2019
- Primary completion1 Feb 2020
- Study completion1 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Intervention group will be compared to historical controls.
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akili Interactive Labs, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elysa J Marco, MD, Principal investigator, Cortica Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03844269
- Sponsor's protocol ID
- 001S-C
- Status last verified
- Oct 2023
- First submitted
- 14 Feb 2019
- Last updated
- 14 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 34972140
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03844269
- Acronym / sponsor ID
- 001S-C
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- ADHD, Inattention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Akili Interactive Labs, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 May 2019 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 18 Feb 2019 (actual)
- Results
- Posted 14 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Intervention group will be compared to historical controls.
| Arm | Type | Receives |
|---|---|---|
| AKL-T01 | Experimental | Device: AKL-T01 |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AKL-T01AKL-T01 digital treatment is a state-of-the-art mobile video game-like platform, which deploys modern videogame graphics, engaging reward loops, and real-time adaptive mechanics to dynamically personalize difficulty based on the user's ability. AKL-T01 multitasking treatment employs perceptual discrimination attention/memory task as well as a continuous motor "driving" task. Performance on these tasks are assessed in isolation and when performed together to calculate a performance index for each individual user. A personalized multitask treatment regimen is automatically configured and delivered to the user and is optimized adaptively to increase multitask performance. As players proceed through the treatment periodic recalibration occurs to maintain an optimal difficulty level. | Device | AKL-T01 |
Primary outcome
Midline Frontal Theta Power (MFT)
Time frame: Day 0 to Day 28
Change in midline frontal theta (MFT) power as measured by Perceptual Discrimination Task (PDT)-Locked Electroencephalogram (EEG).
1 secondary outcome
Midline Frontal Theta Power (MFT)
Time frame: Day 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34972140Gallen 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elysa J Marco, MD principal investigator
Cortica Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AKL-T01 in people with Attention Deficit Hyperactivity Disorder, run by Akili Interactive Labs, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Midline Frontal Theta Power (MFT) (time frame: Day 0 to Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03844269, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2023.