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.
Parkinson's since > 4 years
Patient between years 46-83 (according to the BWS range of validity)
Presence of motor fluctuations as defined by a score ≥ 2 (item 4.3) and a score ≥ 1 (item 4.4) of the MDS-UPDRS part IV
At least 3 doses per day of L-Dopa
No signature of informed consent
Anticipated uncompliance or inability to use the self-reported diary or to wear the devices
Cognitive impairment (MMSE < 24)
Patient treated with second line therapies ((Subcutaneous or digestive pump therapies or deep brain stimulation) or planed for the 6 next months.
Parallel
wearable-based adjustment therapy
Device* Patients will wear the BWS for 7 days prior to each of the visit : baseline (V1) at week 0, V2 at week 4 (phone call at 1 month), V3 at week 12 (3 months visit) and V4 at week 24 (6 months). * Data extracted from each session of monitoring with the BWS will be made available to the neurologist (only in the experimental group) prior to V1 (W0), V2 (W4), V3 (W12) and V4 (W24) respectively * Treatment adjustment will be guided by the current consensus guidelines for treatment adjustment for motor fluctuations in PD using reports from BWS data. Reports will be screened by neurologists before the patient's visit so the groups blinding is correctly observed
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.
The daily time spent in OFF states will be reported by the patient on his/her diary per periods of thirty minutes each day for a duration of 3 days before baseline visit and before 6 months visit. For each day, the total daily time spent OFF will be calculated as the sum of every 30 minutes' periods stated as OFF time. This duration will be averaged over the 3 days period at baseline (W0 +/-7 days) and 6 months (W24 +/- 7 days) visits and the difference between the two visits will be calculated.
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)
For each day, the total time spent in ON state without troublesome dyskinesia will be calculated as the sum of every 30 minutes periods stated as time spent in ON state without troublesome dyskinesia.
Change in time spent in ON state with troublesome dyskinesia between baseline and 6 months on self-reported diary (mean of previous 3 days)
For each day, the total time spent in ON state with troublesome dyskinesia will be calculated as the sum of every 30 minutes periods stated as time spent in ON state with troublesome dyskinesia in the diary. These durations will be averaged over the 3 days period at baseline (W0 +/- 7 days) and 6 months visits (W24 +/- 7 days) and the difference between the two visits will be calculated.
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
The Movement Disorder Society-Unified Parkinson's Disease Rating Scale part II (MDS-UPDRS part II ) score will be assessed at baseline and 6 months visits. The change will be calculated as the difference between the scores obtained at 6 months visit (W24 +/- 7 days) and baseline visit (W0 +/- 7 days). The minimum score of the MDS-UPDRS part II is 0 and the maximum score is 52, the higher score means a worse outcome.
Change of the score of Parkinson Disease Quality of life questionnaire (PDQ-39) related between baseline and 6 months
The Parkinson Disease Quality of life questionnaire (PDQ-39) is a self-questionnaire assessing disease related quality of life in PD. The patient will fill it in at baseline and 6 months visits. The change will be calculated as the difference between the scores obtained at 6 months visit (W24 +/- 7 days) and baseline visit (W0 +/- 7 days). The minimum score of the Parkinson Disease Quality of 0 and the maximum score is 156, the higher score means a worse outcome.
Change in time spent in OFF state between baseline and 6 months based on the BWS assessment
It will be calculated on the basis of the BWS report according to the continuous monitoring of the patient during 7 days. OFF state periods are defined as time with BKS mild (25\<BKS≤39.3 corresponding to BKS above the target range and below the 90th percentile of healthy controls) or BKS severe (39.3\<BKS≤80, corresponding to BKS above the 90th percentile of healthy controls). Change will be calculated as the difference between values obtained at 6 months visit (W24 +/- 7 days) and baseline visit (W0 +/- 7 days).
Change in time spent in good ON state (i.e. time ON without troublesome dyskinesia) between baseline and 6 months based on the BWS assessment.
It will be calculated on the basis of the BWS report according to the continuous monitoring of the patient during 7 days. Time spent in ON state without troublesome dyskinesia will be defined as the sum of all 2' periods within the target range for BKS (BKS≤25) and below the 90th percentile for DKS (DKS≤47.2). Change will be calculated as the difference between values obtained at 6 months visit (W24 +/- 7 days) and baseline visit (W0 +/-7 days).
Change in time spent in ON state with troublesome dyskinesia between baseline and 6 months based on the BWS assessment
It will be calculated on the basis of the BWS report according to the continuous monitoring of the patient during 7 days. Time spent in ON state with troublesome dyskinesia will be defined as the sum of all 2 miutes periods BKS\< 25 (normal range) and DKS\>47.2 (above the 90th percentile). . Change will be calculated as the difference between values obtained at 6 months visit (W24 +/- 7 days) and baseline visit (W0 +/- 7 days).
Concordance of OFF state measure between the diary and the BWS reports
For each patient a concordance rate will be calculated as the number of 30 minutes' period (for all the visits with both diary and BWS assessments) rated as OFF in the diary and measures as OFF in the BWS report , divided by the number of 30 minutes' period rated as OFF in the diary. A period will be considered as OFF with the BWS report if the patient has BKS\>25 during more than 50% of the non-immobile period (BKS≤80).
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Assistance Publique - Hôpitaux de Paris
Lead sponsor
NS-PARK Network
Collaborator
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