Feasibility of the Cranial Remolding Orthosis with Notification Electronics (CROWNE)

This project develops the Cranial Remolding Orthosis with Notification Electronics (CROWNE) to improve the safety and outcomes of cranial remolding treatment. The goal of this effort is to collect previously unmeasured pressure data from at-home treatment with cranial remolding orthoses (CROs) to create a fully verified prototype CROWNE warning system ready for validation testing. CROs are devices used to treat head shape deformities in infants and children, such as craniosynostosis, plagiocephaly and brachycephaly, to improve head shape as the skull grows. Project objectives are to: (1) refine and miniaturize the technology based on input from an expert panel and user focus group to create fully verified CROWNE prototypes ready for at-home testing; (2) perform pre-clinical pilot take-home testing to monitor pressures in the CRO over the course of 2 months of treatment on 12 pediatric subjects; and (3) to use the collected pressure and clinical observations to develop preliminary algorithms that will be used by the CROWNE system to provide feedback to caregivers and clinicians. The resulting measured pressure data from at home CRO treatment can be used to develop the CROWNE warning system and ultimately improve the treatment and clinical outcomes for craniosynostosis and deformational plagiocephaly patients.