NCT07074119Not yet recruiting
Sensor-Based Optimization of Therapy for Parkinson's Disease Patients With Motor Fluctuations
Source: ClinicalTrials.gov · Last updated 2 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 218 (estimated)
- First submitted
- 26 Jun 2025
- Start date
- Oct 2026
- Primary completion date
- 1 Apr 2029
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Parkinson disease
- NCT number
- NCT07074119
What you commit to
- Study type: Interventional
- Planned participants: 218
- From Oct 2026 to the primary completion date, 1 Apr 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient treated with second line therapies ((Subcutaneous or digestive pump therapies or deep brain stimulation) or planed for the 6 next months.
Other illness
- Cognitive impairment (MMSE \< 24)
Other
- No signature of informed consent
- Anticipated uncompliance or inability to use the self-reported diary or to wear the devices
- Pregnant or breastfeeding women
- Patients living in nursing home
- Patient already participating in another clinical investigation or interventional study.
Who the study is looking for
- 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
Age in the registry: 46 years to 83 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre d'investigations cliniques Pitié-Salpêtrière University Hospital Coordinator of this site? Confirm its status | Paris | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.