An Observational Study With the Janssen Autism Knowledge Engine (JAKE®) in Individuals With Autism Spectrum Disorder

The Janssen Autism Knowledge Engine (JAKE®) is a clinical research outcomes assessment system developed to more sensitively measure treatment outcomes and identify subpopulations in autism spectrum disorder (ASD). Here we describe JAKE and present results from its digital phenotyping (My JAKE) and b...

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Published in:Frontiers in neuroscience Vol. 13; p. 111
Main Authors: Ness, Seth L., Bangerter, Abigail, Manyakov, Nikolay V., Lewin, David, Boice, Matthew, Skalkin, Andrew, Jagannatha, Shyla, Chatterjee, Meenakshi, Dawson, Geraldine, Goodwin, Matthew S., Hendren, Robert, Leventhal, Bennett, Shic, Frederick, Frazier, Jean A., Janvier, Yvette, King, Bryan H., Miller, Judith S., Smith, Christopher J., Tobe, Russell H., Pandina, Gahan
Format: Journal Article
Language:English
Published: Switzerland Frontiers Research Foundation 27.02.2019
Frontiers Media S.A
Subjects:
assessment
Autism
autism spectrum disorder (ASD)
Behavior
Biomarkers
biosensor
Biosensors
Brain research
Children & youth
Clinical trials
Data processing
EEG
EKG
Electroencephalography
Eye movements
mood report
Nervous system
Neurobiology
Neuroscience
Neurosciences
Observational studies
Pediatrics
Phenotyping
Physiology
Psychiatry
R&D
Research & development
Sleep
Subpopulations
web and mobile application
United States > US
San Francisco California
mood report
assessment
web and mobile application
biosensor
autism spectrum disorder (ASD)
ISSN:1662-453X, 1662-4548, 1662-453X
Online Access:Get full text
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Summary:The Janssen Autism Knowledge Engine (JAKE®) is a clinical research outcomes assessment system developed to more sensitively measure treatment outcomes and identify subpopulations in autism spectrum disorder (ASD). Here we describe JAKE and present results from its digital phenotyping (My JAKE) and biosensor (JAKE Sense) components. An observational, non-interventional, prospective study of JAKE in children and adults with ASD was conducted at nine sites in the United States. Feedback on JAKE usability was obtained from caregivers. JAKE Sense included electroencephalography, eye tracking, electrocardiography, electrodermal activity, facial affect analysis, and actigraphy. Caregivers of individuals with ASD reported behaviors using My JAKE. Results from My JAKE and JAKE Sense were compared to traditional ASD symptom measures. Individuals with ASD ( = 144) and a cohort of typically developing (TD) individuals ( = 41) participated in JAKE Sense. Most caregivers reported that overall use and utility of My JAKE was "easy" (69%, 74/108) or "very easy" (74%, 80/108). My JAKE could detect differences in ASD symptoms as measured by traditional methods. The majority of biosensors included in JAKE Sense captured sizable amounts of quality data (i.e., 93-100% of eye tracker, facial affect analysis, and electrocardiogram data was of good quality), demonstrated differences between TD and ASD individuals, and correlated with ASD symptom scales. No significant safety events were reported. My JAKE was viewed as easy or very easy to use by caregivers participating in research outside of a clinical study. My JAKE sensitively measured a broad range of ASD symptoms. JAKE Sense biosensors were well-tolerated. JAKE functioned well when used at clinical sites previously inexperienced with some of the technologies. Lessons from the study will optimize JAKE for use in clinical trials to assess ASD interventions. Additionally, because biosensors were able to detect features differentiating TD and ASD individuals, and also were correlated with standardized symptom scales, these measures could be explored as potential biomarkers for ASD and as endpoints in future clinical studies. https://clinicaltrials.gov/ct2/show/NCT02668991 identifier: NCT02668991.
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Edited by: Stephen Louis Macknik, SUNY Downstate Medical Center, United States
This article was submitted to Neural Technology, a section of the journal Frontiers in Neuroscience
Reviewed by: Brent Winslow, Design Interactive, United States; Emilia Biffi, Eugenio Medea (IRCCS), Italy
ISSN:1662-453X
1662-4548
1662-453X
DOI:10.3389/fnins.2019.00111