Clinical Trial

Sensor-Based Optimization of Therapy for Parkinson's Disease Patients With Motor Fluctuations

Study acronym: SO-TOP
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Summary
Although numerous tools have been developed in recent years with the enhancement of new technologies precision and the reduction of their size, still few medical devices are used in clinical routine in Parkinson's Disease. Knowledge about Parkinson's Disease motor symptoms has been widely improved especially thanks to objective monitoring of movements. However, patients are mostly observed in defined environment during scripted activities, which is per se distinct from the real life conditions. Besides, experts may agree on the limitations of the diary that is supposed to reflect the patient's status at home, while outpatients' visits may also not correctly enable the neurologist to catch up the everyday life condition of the patient. In order to overcome some of these issues, we hypothesize that the implementation of body-worn sensors at home monitoring could provide promising solutions. Yet, important information is missing: there is no previous randomized trial studying the additional value of body-worn sensors to improve motor symptoms, quality of life and ability to perform everyday life activities for example. To our knowledge, our study proposal is the first one to adjust therapy of patients with Parkinson's Disease based on the reports of body-worn sensors monitoring. If the efficacy and reliability of at home monitoring with sensors is proven, new healthcare guidelines could arise with the objective of a better and continuous patient's follow-up, remotely from the outpatient's visit.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-07-17; most recent amendment 2026-01-02.
Trial Details
NCT Number NCT07074119
Lead Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators: NS-PARK Network
Conditions Parkinson Disease (PD)
Enrollment 218 participants
Start Date 2026-03
Primary Completion 2028-09-01 (estimated)
Study Completion 2028-10 (estimated)
Updated on ClinicalTrials.gov 2026-01-05