Shortly after presenting Soturi at Frontiers Health 2023, Newel Health, a digital therapeutic solution provider, announced that three centers are involved in the recruiting and onboarding for its clinical study, “NWL-SOT-CS-001,” aimed at leveraging Real-World Data to enhance Parkinson’s disease treatment.

The study prioritizes free-living data collection to understand patients’ daily challenges, symptoms’ patterns, adherence to medication and the overall response to medication to validate algorithms for treatment optimization. With the recruitment phase started, the data collection phase is now underway, using the Soturi mobile app and a smart device for digital data capture over a 6-month period. Led by Prof. Maria Teresa Pellecchia at University Hospital San Giovanni di Dio e Ruggi d’Aragona in Salerno, Italy, alongside two centers in Rome, Santa Lucia Foundation IRCCS Outpatient Clinic for Parkinson’s Disease and Movement Disorders – Laboratory of Neuropsychiatry, and the Parkinson’s disease research centre Institute for Research and Medical Care IRCCS San Raffaele, this innovative research initiative is generously funded by The Michael J. Fox Foundation for Parkinson’s Research.

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Prioritizing free-living data collection, the study bridges the gap between traditional clinical monitoring and the challenges faced by Parkinson’s patients. By exploring medication’s impact on symptom fluctuations, the study strives to develop a model for refining medication plans and reducing OFF periods. The Soturi mobile app, a key component, provides digital companion features, paired with a wearable smart device for seamless data capture over a 6-month period.

This study strategically complements Newel’s R&D activities, addressing gaps in previous research. Actively recruiting for the next two months, it will culminate in the last patient’s final visit in approximately eight months.

“This study aims to address a significant unmet need for individuals with Parkinson’s disease: the accurate identification and remote monitoring of motor symptoms, motor fluctuations, and dyskinesia in real-world scenarios. Neurologists from three esteemed centers will collaborate to validate the clinical effectiveness of Soturi’s digital health technology in providing real-time insights for optimizing and personalizing medication schedules for patients with Parkinson’s disease,” declares Prof. Maria Teresa Pellecchia, Principal Investigator, University Hospital San Giovanni di Dio e Ruggi d’Aragona.

“In the field of personalized management of Parkinson’s disease, information gathered during conventional clinical visits often falls short. Recognizing the imperative to base insights on ecological data, we aim to provide a comprehensive understanding through accurate reports of patient symptomatology in everyday contexts, facilitated by data obtained from wearable devices,” said Dr. Clelia Pellicano, Principal Investigator, Santa Lucia Foundation IRCCS Outpatient Clinic for Parkinson’s Disease and Movement Disorders – Laboratory of Neuropsychiatry.

“As the Clinical Trial Manager for Newel Health, I’m pleased to coordinate a clinical study that marks a significant step in implementing digital data and endpoint collection. This initiative is crucial as we transition towards studies that demand more Real-World Data, allowing us to capture the nuanced variability often missed in standard clinical studies’ visits. By prioritizing free-living data and leveraging digital technologies, we aim to bridge the gap between traditional monitoring and the complex real-world experiences of Parkinson’s disease patients, paving the way for more comprehensive and impactful research outcomes,” said Giovanni Gentile, Clinical Trial Manager, Newel Health.

This study is funded by The Michael J. Fox Foundation for Parkinson’s Research, Grant ID: MJFF-022711.