Patient Monitoring and Clinical Trial Considerations for the Development of Extraclinical Neurostimulation Therapy for Pediatric ADHD

Attention deficit hyperactivity disorder (ADHD) is a neuropsychiatric disorder characterized by a repeated pattern of inattention, hyperactivity, and impulsivity that pervades and inhibits daily life functions. ADHD is most commonly clinically managed using pharmacotherapy, but in pediatric ADHD populations, the use of stimulant medications is somewhat undesirable because of their high cost, impermanence, and numerous side effects. Neurostimulation is an emerging therapeutic alternative to pharmacotherapy, but the commercialization of a neurostimulation device for pediatric ADHD must consider how electrodes should be held near the head for a period of time in the order of hours. The prescription, distribution, and usage of a pediatric ADHD neurostimulation device must be carefully considered in the context of the patient, a child with a unique combination of inattention, hyperactivity, and impulsivity. This work strived to analyze the distinct pain points present in the pediatric ADHD treatment market through stakeholder engagement, to develop an adherence monitoring system using the internet of things, to propose a pilot clinical trial protocol, and to create a model and run fabricated data. Overall, the stakeholder engagement process revealed a significant pain point in the remote monitoring of ADHD therapeutics, which informed the development of an IoT-based adherence monitoring system. This system was designed to collect the elapsed time of a treatment session and transmit that data to the cloud via BLE and a mobile device. Finally, a clinical trial protocol was developed to determine the potential effects of color and color choice as influencing factors on pediatric ADHD patient therapeutic adherence rates. Three distinct models were developed and used to analyze fabricated data sets. These models were then used to draw conclusions about future work regarding pediatric ADHD therapeutic devices