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

NCT07074119 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 218

Last updated 2026-01-05

No results posted yet for this study

Summary

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.

Conditions

  • Parkinson Disease (PD)

Interventions

DEVICE

wearable-based adjustment therapy

* 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

Sponsors & Collaborators

  • NS-PARK Network

    collaborator UNKNOWN

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • David Grabli, Professor · Assistance Publique - Hôpitaux de Paris

  • Jean Chritophe Corvol, Professor · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
46 Years
Max Age
83 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2028-09-01
Completion
2028-10-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07074119 on ClinicalTrials.gov