Abstract
Digital health technologies for people with epilepsy (PWE) include internet-based resources and mobile apps for seizure management. Since non-pharmacological interventions, such as listening to specific Mozart's compositions, cognitive therapy, psychosocial and educational interventions were shown to reduce epileptic seizures, these modalities can be integrated into mobile software and delivered by mobile medical apps as digital therapeutics. Herein, we describe: (1) a survey study among PWE about preferences to use mobile software for seizure control, (2) a rationale for developing digital therapies for epilepsy, (3) creation of proof-of-concept mobile software intended for use as an adjunct digital therapeutic to reduce seizures, and (4) broader applications of digital therapeutics for the treatment of epilepsy and other chronic disorders. A questionnaire was used to survey PWE with respect to preferred features in a mobile app for seizure control. Results from the survey suggested that over 90% of responders would be interested in using a mobile app to manage their seizures, while 75% were interested in listening to specific music that can reduce seizures. To define digital therapeutic for the treatment of epilepsy, we designed and created a proof-of-concept mobile software providing digital content intended to reduce seizures. The rationale for all components of such digital therapeutic is described. The resulting web-based app delivered a combination of epilepsy self-care, behavioral interventions, medication reminders and the antiseizure music, such as the Mozart's sonata K.448. To improve long-term patient engagement, integration of mobile medical app with music and multimedia streaming via smartphones, tablets and computers is also discussed. This work aims toward development and regulatory clearance of software as medical device (SaMD) for seizure control, yielding the adjunct digital therapeutic for epilepsy, and subsequently a drug-device combination product together with specific antiseizure medications. Mobile medical apps, music, therapeutic video games and their combinations with prescription medications present new opportunities to integrate pharmacological and non-pharmacological interventions for PWE, as well as those living with other chronic disorders, including depression and pain.
Highlights
Among people with epilepsy (PWE) and their healthcare providers, there are overlapping needs for better control of: (1) seizures, (2) medication adherence and (3) comorbidities
We provide a rationale for mobile medical app content which integrates antiseizure music, epilepsy self-care and elements of cognitive behavioral therapy
In relation to monitoring epilepsy, 85% of patients were interested in diary to record date of their seizures, 73% were interested in recording type of their seizures, 78% were interested in logging the missed dosages of their medications
Summary
Among people with epilepsy (PWE) and their healthcare providers, there are overlapping needs for better control of: (1) seizures, (2) medication adherence and (3) comorbidities. Newly-diagnosed patients have approximately 50% chance to become seizure free after taking their first antiseizure medication (Brodie et al, 2012, 2013; Chen et al, 2017). Recent work suggests that even after becoming seizure-free, over 60% of patients who discontinue taking antiseizure drugs experienced at least one relapse over a period of 3 years (Park et al, 2017). 30% of PWE do not adhere to medication schedules, leading to decreased seizure control (Ettinger et al, 2009; Malek et al, 2017; O’ Rourke and O’ Brien, 2017). There are multiple needs to develop new therapies with improved efficacy and clinical outcomes for PWE
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