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

The study is Single Blind Randomized clinical trial. The participants are patients with Parkinson's Disease at the stage of motor fluctuations without dementia or levodopa-resistant axial symptoms who need therapeutic adjustments according to the neurologist opinion. The primary objectif is to assess the efficacy of the Body Worn Sensors (BWS)-based adjustment therapy, on add-on to usual care, on change in time spent in OFF state in PD patients with motor fluctuation requiring treatment adaptation. The primary endpoint is the change in daily time spent in OFF state between baseline and 6 months visit, measured as the mean daily time in OFF state upon 3 days on self-reported diary. Medical device under investigation, CE-marked (class IIA) under regulation UE 2017/745, is a body-worn sensor (BWS) that measures movements and analyses accelerometry data to report motor symptoms of Parkinson's Disease. The product is the PKG system (Global Kinetics Corporation, Melbourne Australia). This BWS embarks a dedicated algorithm that continuously reports severity scores of bradykinesia, dyskinesia and tremor over a week of monitoring. All the patients will wear the PKG Watch but results from BWS recording will be available for the neurologist to adapt the treatment, according to randomization allocation (Available in the experimental group only). In both groups (experimental and control group), the treatment will be adapted according to current guidelines. Four follow-up visits will be performed at M0 (W0), M1 (W4 +/- 7 days), M3 (W12 +/- 7 days) and M6 (W24 +/- 7 days) during outpatients clinics (except for M1 = phone call) where participants are usually followed. 13 centers in France participating to the NS-PARK network (French research Network for PD). The duration of recruitment will be 24 months. The duration of participation for each participant will be 6 months, the total duration of the study will be 31 months. For this study, 218 patients will be recruited.

• Change in time spent in good ON state without troublesome dyskinesia (i.e. good time ON) between baseline and 6 months on self-reported diary (mean of previous 3 days) [Срок оценки: Baseline (W0) and 6 months visits (W24)]
• Change in time spent in ON state with troublesome dyskinesia between baseline and 6 months on self-reported diary (mean of previous 3 days) [Срок оценки: baseline (W0) and 6 months visits (W24)]
• Change of Movement Disorder Society-Unified Parkinson's Disease Rating Scale part II (MDS-UPDRS part II-motor aspects of experiences of daily living) between baseline and 6 months [Срок оценки: baseline (W0) and 6 months visits (W24)]
• Change of the score of Parkinson Disease Quality of life questionnaire (PDQ-39) related between baseline and 6 months [Срок оценки: baseline (W0) and 6 months visits (W24)]
• Number of patients with at least one dopaminergic drug-related side effects between groups during the study period. [Срок оценки: baseline (W0), 1 month visit (W4), 3 months visit (W12) and 6 months (W24)]
• Number of patients with each type of Dopaminergic drug-related [Срок оценки: baseline (W0), phone call at 2 months (W4 ), 3 months visit (W12 ), 6 months visit (W24)]
• Change of Movement Disorder Society-Unified Parkinson's Disease Rating Scale part I (MDS-UPDRS part I-non-motor aspects of experiences of daily living) between baseline and 6 months [Срок оценки: baseline (W0) and 6 months visits (W24)]
• Changes in drug regimen during the study of Levodopa equivalent daily doses (LEDD) between baseline and 6 months [Срок оценки: baseline (W0) and 6 months visit (W24)]
• Changes in drug regimens between baseline and 6 months [Срок оценки: baseline (W0) and 6 months visits (W24)]
• Number of consultations between baseline visit (W0) and 6 months visit [Срок оценки: baseline (W0) and 6 months visits (W24)]
• Number of hospitalization days between baseline visit (W0) and 6 months visit [Срок оценки: baseline (W0) and 6 months visits (W24)]