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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-A00322-55 | Other Identifier | ANSM |
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| Name | Class |
|---|---|
| NS-PARK Network | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Patients of the control group will undergo the same protocol as patients in the experimental arm. However, data extracted from the BWS will be made available to the neurologist. |
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| Control group | Active Comparator | Patients of the control group will undergo the same protocol as patients in the experimental arm. However, data extracted from the BWS will be blinded and NOT be made available to the neurologist. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| wearable-based adjustment therapy | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (W0) and 6 months visit (W24) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (W0) and 6 months visits (W24) |
| Measure | Description | Time Frame |
|---|---|---|
| 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\ |
Inclusion criteria :
Exclusion criteria :
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David Grabli, Professor | Contact | 01 42 16 24 61 | david.grabli@aphp.fr | |
| Sofia Zemouri, Master | Contact | 01 42 16 75 75 | sofia.zemouri@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| David Grabli, Professor | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Jean Chritophe Corvol, Professor | Assistance Publique - Hôpitaux de Paris | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre d'investigations cliniques Pitié-Salpêtrière University Hospital | Paris | Île-de-France Region | 75013 | France |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D020820 | Dyskinesias |
| D018476 | Hypokinesia |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| 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. | 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 | 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. | 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 | 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. | 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. | Dopaminergic drug-related side effects will be collected at each visit: baseline (W0 +/- 7 days), phone call at 1 months (W4 +/- 7 days), 3 months visit (W12 +-/ 7 days), 6 months visit (W24 +/- 7 days). AE will be classified as related or not with anti-parkinsonian drug and rated according to their severity. The number and severity of anti-parkinsonian drug side effects will be compared across groups. | baseline (W0), 1 month visit (W4), 3 months visit (W12) and 6 months (W24) |
| Number of patients with each type of Dopaminergic drug-related | The side effects will be described in each group | 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 | Movement Disorder Society-Unified Parkinson's Disease Rating Scale part I (MDS-UPDRS part I) 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 I is 0 and the maximum score is 52, the higher score means a worse outcome. | 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 | The change in LEDD between 6 months visit (V4) and baseline visit (V1) will be calculated as the difference. | baseline (W0) and 6 months visit (W24) |
| Changes in drug regimens between baseline and 6 months | Antiparkinsonian and associated treatments will be systematically collected at baseline (W0 +/- 7 days) and 6 months (W24 +/- 7 days) visits. The number and type of changes (i.e. addition of drugs, discontinuation of drugs, increase / decrease of dosing) between baseline visit (W0) and 6 months visit (W24 +/- 7 days) will be described. | baseline (W0) and 6 months visits (W24) |
| Number of consultations between baseline visit (W0) and 6 months visit | Number of consultations (general practitioner, neurologist, other specialist, advanced practice nurse) between baseline visit (W0) and 6 months visit (W24 +/- 7 days) | baseline (W0) and 6 months visits (W24) |
| Number of hospitalization days between baseline visit (W0) and 6 months visit | baseline (W0) and 6 months visits (W24) |
| baseline (W0) and 6 months visits (W24) |
| 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). | baseline (W0) and 6 months visits (W24) |
| 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). | baseline (W0) and 6 months visits (W24) |
| 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). | baseline (W0) and 6 months visits (W28) |
| Concordance of the good time ON state (i.e. time ON without troublesome dyskinesia) 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 good time ON in the diary and measures as good ON state in the BWS report, divided by the number of 30 minutes' period rated as good time ON in the diary. A period will be considered as good ON state with the BWS report if the patient has BKS≤25 and DKS≤47.2 during more than 50% of the non-immobile period (BKS≤80). | baseline (W0) and 6 months visits (W24) |
| Concordance of the time ON state with troublesome dyskinesia in the diary and the time with dyskinesia given by the BWS report | 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 time ON with troublesome dyskinesia in the diary and measures as time with dyskinesia in the BWS report, divided by the number of 30 minutes' period rated as time ON with troublesome dyskinesia in the diary.A period will be considered as ON state with troublesome dyskinesia with the BWS report if the patient has BKS ≤25 and DKS > 47.2 during more than 50% of the non-immobile period (BKS≤80). | baseline (W0) and 6 months visits (W24) |
| The attractiveness of the Body Worn Sensor (BWS) from patients | The attractiveness will be assessed by scores of a user experience questionnaire System Usability Scale (SUS) at 6 months. The SUS will be filled-in separately by patients (in the 2 groups) at 6 months (W24+/- 7 days) visit. | 6 months visit (W24) |
| The attractiveness of the Body Worn Sensor (BWS) from neurologists | The attractiveness will be assessed by scores of a user experience questionnaire System Usability Scale (SUS ) at 6 months. The SUS will be filled-in neurologists only in the BWS-based adjustment group. | 6 months visit (W24) |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |