JAKE® Multimodal Data Capture System: Insights from an Observational Study of Autism Spectrum Disorder

Abstract

Objective: To test usability and optimize the Janssen Autism Knowledge Engine (JAKE®) system's components, biosensors, and procedures used for objective measurement of core and associated symptoms of autism spectrum disorder (ASD) in clinical trials. Methods: A prospective, observational study of 29 children and adolescents with ASD using the JAKE system was conducted at three sites in the United States. This study was designed to establish the feasibility of the JAKE system and to learn practical aspects of its implementation. In addition to information collected by web and mobile components, wearable biosensor data were collected both continuously in natural settings and periodically during a battery of experimental tasks administered in laboratory settings. This study is registered at clinicaltrials.gov, NCT02299700. Results: Feedback collected throughout the study allowed future refinements to be planned for all components of the system. The Autism Behavior Inventory (ABI), a parent-reported measure of ASD core and associated symptoms, performed well. Among biosensors studied, the eye-tracker, sleep monitor, and electrocardiogram were shown to capture high quality data, whereas wireless electroencephalography was difficult to use due to its form factor. On an exit survey, the majority of parents rated their overall reaction to JAKE as positive/very positive. No significant device-related events were reported in the study. Conclusion: The results of this study, with the described changes, demonstrate that the JAKE system is a viable, useful, and safe platform for use in clinical trials of ASD, justifying larger validation and deployment studies of the optimized system.

Keywords: assessment; autism spectrum disorder (ASD); biomarker; biosensor; software.

Figure 1

Janssen Autism Knowledge Engine.

Figure 2

View of journal and event entries (A) and new journal entry field (B). The child's name and journal/event entries are fictional, not original.

Figure 3

Chart indicating biosensor features. Written, informed consent was obtained from the parents for publication of their child's image. The child's name is fictional.

Figure 4

Event tracker screen—mobile version.

Figure 5

Power Spectral Density (PSD) for social and non-social stimuli averaged among central electrode positions for a single TD participant from the study. Vertical strips denote delta, theta, alpha, beta, and gamma bands. Alpha power is suppressed and theta power is enhanced during observation of social stimuli in comparison to non-social ones. For ASD participants, differences in alpha and theta are expected to be inversed or negligible (Dawson et al., 2012).

Figure 6

Event-related responses averaged along parietal electrodes for facial stimuli with averted and direct gazes for a single ASD participant from the study. Vertical stripe indicates interval for N170 estimation. Amplitude of N170 component for averted gaze stimuli is lower than that for direct gaze stimuli. We expect to see differences in amplitude/latency of N170 between two stimuli conditions in the ASD population, with no differences for TD participants (Grice et al., 2005).

Figure 7

Raw EDA data from a single TD participant. The vertical stripes denote the three sets into which the stimuli were divided. Increase in SCL indicates the participant's increasing arousal toward the end of the task battery.

Figure 8

Results of exit survey completed by parents/caregivers of ASD children. (A) Rate your experience navigating and using the different parts of JAKE. (B) Rate your overall reaction to JAKE. (C) Would you like to use JAKE again? (D) Would you use the symptom tracker outside of a clinical trial (i.e., even if it were not required)?

Figure 9

Revised daily tracker. The child's name and tracker field are fictional.