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

Study acronym: SO-TOP
StatusNot Yet Recruiting
PhaseNot applicable
Started2026-10
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 7 months later Sep 1, 2028 → Apr 1, 2029
See other at-risk trials from Assistance Publique - Hôpitaux de Paris

Amendment history

2026-08-31
critical
Study Status, Conditions, IPDSharing v3
Primary completion pushed: 2028-09-01 → 2029-04-01
Completion pushed: 2028-10 → 2029-10
Start date2026-03→2026-10
2026-01-02
minor
Study Status v2
Primary completion date2028-05-01→2028-09-01
Completion date2028-07→2028-10
Start date2025-12-01→2026-03
2025-12-05
minor
Study Status, Outcome Measures, Eligibility v1
Completion date2028-09→2028-07
Start date2025-10-01→2025-12-01
Eligibility criteria-6 characters
[...] a score ≥ 1 (item 4.4) of the MDS-UPDRS part IV At least 3 ordoses moreper dosingday of L-Dopa during the day Need of therapeutic adjustment because of motor fluctuation [...] ent (MMSE < 24) Patient treated with second line therapies (Apomorphine(Subcutaneous or digestive pump, Levodopa pumptherapies or deep brain stimulation) or planed for the 6 next months. [...]
Secondary endpoints10 to 11 entries
Number andof severitypatients ofwith at least one dopaminergic drug-related side effects between groups during the study period. Number of patients with each type of Dopaminergic drug-related
2025-07-17
minor
Original filing
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.
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 2026-10
Primary Completion 2029-04-01 (estimated)
Study Completion 2029-10 (estimated)
Updated on ClinicalTrials.gov 2026-09-02