Enrolment starts in trial of AI-powered Parkinson’s therapy

Newel Health

Patient recruitment is now underway in a clinical trial of Newel Health’s digital therapeutic for Parkinson’s disease, which hopes to show it can enhance the efficacy of treatment.

The long-term plan for the artificial intelligence-driven decision support system – called Soturi – is to draw on data collected from a wearable sensor and a proprietary algorithm to optimise and personalise treatment for people living with the neurodegenerative disorder.

The version being trialed in the new study uses a smart band equipped with inertial sensors to track movements which will detect symptom patterns, and will eventually allow physicians to monitor the frequency and severity of symptoms and receive treatment recommendations from the system.

Enrolment of patients into the NWL-SOT-CS-001 trial, which has received funding from the Michael J Fox Foundation, has started at three centres in Italy, with real-world data already being collected from the first subjects.

The aim is to gather free-living data from participants to understand how Parkinson’s is affecting their daily lives, tracking symptom patterns and adherence to medication, as well as their overall response to treatment.

The data will be collected over six months and used to validate algorithms that can be used to optimise treatment, according to Newel Health, which says it aims to bridge the gap between traditional clinical monitoring and the challenges faced by Parkinson’s patients.

One key objective will be to explore how the data may be used to refine medication plans to reduce so-called ‘off’ periods when Parkinson’s symptoms re-emerge between medication doses. Not everyone experiences this phenomenon, but it is more common in those living with Parkinson’s or taking medication over many years.

The trial should be completed in around eight months, according to the investigators, who are led by Prof Maria Teresa Pellecchia at University Hospital San Giovanni di Dio e Ruggi d’Aragona in Salerno.

“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,” remarked Prof Pellecchia.

“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,” she added.

The other two centres 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 in Rome.

Soturi was developed in collaboration with Orion Corp, which has been manufacturing drugs used to treat patients with Parkinson’s disease for more than 40 years.

“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,” said Giovanni Gentile, clinical trial manager at Newel Health.

Editor's Note: This story has been edited at the request of Newel Health to clarify that certain descriptions refer to planned features of the system, not to the version currently in market.