Sensor-Based Optimization of Therapy for Parkinson's Disease Patients With Motor Fluctuations (SO-TOP)

Assistance Publique - Hôpitaux de Paris

Status: Begins enrollment this month

Conditions: Parkinson Disease (PD)

Treatments: Device: wearable-based adjustment therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07074119

APHP180609

2019-A00322-55 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 218 estimated patients

Sex: All

Ages: 46 to 83 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria :

• 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
• Need of therapeutic adjustment because of motor fluctuations according to the neurologist opinion
• Hoehn and Yahr stage ≤ 3 in OFF state

Exclusion criteria :

• 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.
• Pregnant or breastfeeding women
• Patients living in nursing home
• Patient already participating in another clinical investigation or interventional study.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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218 participants in 2 patient groups

Experimental group

Experimental group

Description:

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.

Treatment:

Device: wearable-based adjustment therapy

Control group

Active Comparator group

Description:

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.

Treatment:

Device: wearable-based adjustment therapy