A Study to Assess the Janssen Autism Knowledge Engine in Children with Autism
Seth Ness, MD (Janssen) Matthew Goodwin, PhD (Northeastern)
Tags: Under 5; 5 to 10; 10 to 18; Over 18; Treatment
Location: Northeastern University
The main goal of this study is to evaluate the usability of the JAKE as a system to monitor clinical outcomes in ASD.
Doctor Goodwin is doing this study for the sponsor. An independent ethics committee or institutional review board has approved the study.
About 80 patients ages 3 through adult will take part in this US study.
- An interface to an autism personal healthcare record (pHR) with tools and technologies tailored to parents and individuals with ASD and their healthcare providers. JAKE is the user interface and Microsoft HealthVault is the pHR.
- Biosensors to assess physiological characteristics and behavior related to core symptoms of ASD.
a. Biosensors are devices that measure things your body is doing. The sponsor will use this information to try to better understand autism. In this study some biosensors that will be used include measuring your child’s brain activity, tracking where your child’s eyes are looking, checking your child’s heart rate, tracking how much you and your child move, and measuring your child’s skin temperature and how much your child sweats.
- A research data warehouse (RDW) that will hold a portion of the study data without identifying you or your child. The data warehouse can be explored using analytic tools and strategies to track treatment outcomes, assess symptom patterns and subpopulations. It may also be used as a resource for future clinical trials, to develop new analytic software, or to understand and interpret significant biosensor data events. The information stored in the RDW may be shared with external parties not directly affiliated with the Sponsor for the purposes of scientific collaboration and research.