Newel Health has announced the launch of a clinical trial evaluating its digital therapeutic app designed to help patients with Parkinson’s disease optimise their personalised treatment plans.
The Soturi app, created in collaboration by Orion Pharma and Healthware Therapeutics, uses data collected from a wearable sensor and an algorithm-based decision-making method to deliver relevant services to people living with the neurodegenerative disorder.
The app also features symptom monitoring, automated detection of symptoms via a wearable bracelet, as well as medication reminders.
Three centres in Italy are involved in the recruiting and onboarding for the NWL-SOT-CS-001 study, which has received funding from the Michael J Fox Foundation for Parkinson’s Research.
With recruitment underway, the data collection phase has now begun, using the Soturi app and a smart device for digital data capture over six months.
Newel noted that by prioritising free-living data collection to understand patients’ daily challenges, symptom patterns, adherence to medication and the overall response to treatment, 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 [when Parkinson’s symptoms return between medication doses],” the company said.
Professor Maria Teresa Pellecchia, principal investigator, University Hospital San Giovanni di Dio e Ruggi d’Aragona in Salerno, said: “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 centres will collaborate to validate the clinical effectiveness of Soturi’s digital health technology in providing real-time insights for optimising and personalising medication schedules for patients with Parkinson’s disease.”
The other two centres involved in the study are the 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, both based in Rome.