Trial Outcomes & Findings for Electroencephalogram (EEG) Study of Inattention Following Treatment With AKL-T01 (NCT NCT03844269)
NCT ID: NCT03844269
Last Updated: 2023-11-14
Results Overview
Change in midline frontal theta (MFT) power as measured by Perceptual Discrimination Task (PDT)-Locked Electroencephalogram (EEG).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
28 participants
Primary outcome timeframe
Day 0 to Day 28
Results posted on
2023-11-14
Participant Flow
Participant milestones
| Measure |
AKL-T01
AKL-T01: 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.
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|---|---|
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Overall Study
STARTED
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28
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Overall Study
COMPLETED
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25
|
|
Overall Study
NOT COMPLETED
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3
|
Reasons for withdrawal
| Measure |
AKL-T01
AKL-T01: 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.
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|---|---|
|
Overall Study
Withdrawal pre-intervention
|
1
|
|
Overall Study
Did not complete the intervention
|
2
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Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
AKL-T01
n=25 Participants
AKL-T01: 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.
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|---|---|
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Age, Continuous
|
10.44 years
STANDARD_DEVIATION 1.23 • n=25 Participants
|
|
Sex: Female, Male
Female
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5 Participants
n=25 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=25 Participants
|
|
Region of Enrollment
United States
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25 participants
n=25 Participants
|
PRIMARY outcome
Timeframe: Day 0 to Day 28Population: Exclusions: data with excessive noise at the pre- or post-intervention assessment. Excessive noise was defined as rejection of more than 30% of target trials due to voltage fluctuations greater than ± 100 μV deflections within an epoch.
Change in midline frontal theta (MFT) power as measured by Perceptual Discrimination Task (PDT)-Locked Electroencephalogram (EEG).
Outcome measures
| Measure |
AKL-T01
n=22 Participants
AKL-T01: 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.
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Neurotypical Historical Control
EEG data from neurotypical participants from a prior study, "A pilot study to determine the feasibility of enhancing cognitive abilities in children with sensory processing dysfunction" (Anguera, 2017) was used as historical controls. All participants underwent 4-weeks of treatment with AKL-T01.
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|---|---|---|
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Midline Frontal Theta Power (MFT)
Mean change in time window 0-120 ms
|
-0.31835 Hertz
Standard Deviation 0.54423
|
—
|
|
Midline Frontal Theta Power (MFT)
Mean change in time window 160-280 ms
|
-0.15256 Hertz
Standard Deviation 0.79222
|
—
|
|
Midline Frontal Theta Power (MFT)
Mean change in time window 760-875 ms
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-0.29013 Hertz
Standard Deviation 0.64112
|
—
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SECONDARY outcome
Timeframe: Day 28Population: Exclusions: data with excessive noise at the pre- or post-intervention assessment. Excessive noise was defined as rejection of more than 30% of target trials due to voltage fluctuations greater than ± 100 μV deflections within an epoch.
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).
Outcome measures
| Measure |
AKL-T01
n=22 Participants
AKL-T01: 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.
|
Neurotypical Historical Control
n=18 Participants
EEG data from neurotypical participants from a prior study, "A pilot study to determine the feasibility of enhancing cognitive abilities in children with sensory processing dysfunction" (Anguera, 2017) was used as historical controls. All participants underwent 4-weeks of treatment with AKL-T01.
|
|---|---|---|
|
Midline Frontal Theta Power (MFT)
Pre-intervention Mean MFT power (0-120 ms)
|
.09047 Hertz
Standard Deviation .625799
|
-.34779 Hertz
Standard Deviation 1.278674
|
|
Midline Frontal Theta Power (MFT)
Post-intervention Mean MFT power (0-120 ms)
|
.39812 Hertz
Standard Deviation .411608
|
-.11458 Hertz
Standard Deviation 1.1151529
|
|
Midline Frontal Theta Power (MFT)
Pre-intervention Mean MFT power (200-320 ms)
|
.81225 Hertz
Standard Deviation .931336
|
.54878 Hertz
Standard Deviation 2.391647
|
|
Midline Frontal Theta Power (MFT)
Post-intervention Mean MFT power (200-320 ms)
|
1.06766 Hertz
Standard Deviation .729074
|
1.09948 Hertz
Standard Deviation 1.804712
|
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Midline Frontal Theta Power (MFT)
Pre-intervention Mean MFT power (680-800 ms)
|
-.02013 Hertz
Standard Deviation .436377
|
-.05245 Hertz
Standard Deviation 2.444086
|
|
Midline Frontal Theta Power (MFT)
Post-intervention Mean MFT power (680-800 ms)
|
.35505 Hertz
Standard Deviation .607502
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-.58763 Hertz
Standard Deviation 1.678055
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Adverse Events
AKL-T01
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60