Actively Recruiting
Enabling Women with Parkinson's Disease to Identify and Better Manage Hormonal Triggers
Led by University Hospital, Grenoble · Updated on 2025-03-25
100
Participants Needed
4
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the impact of the menstrual and hormonal cycle on Parkinson's disease (PD) symptoms in pre-menopausal women. This study focuses on tracking changes in motor and non-motor symptoms during the menstrual cycle and aims to improve symptom management through neurologist intervention and patient self-management. The project uses digital technology to better understand how hormonal changes affect PD symptoms and to provide tailored care. Participants will use the My Moves Matter (MMM) mobile application to report their PD symptoms throughout their hormonal cycle over several months. A wearable device called PDMonitor will also be used by some participants to objectively track motor changes. The study will assess the reliability of the app, compare subjective symptom reports with objective clinical measures, and evaluate the effectiveness of clinical interventions suggested by neurologists based on app data during a 3-month evaluation period. Women involved in the study will regularly use the mobile app to log their symptoms and may use the PDMonitor device for motor symptom tracking. Researchers will monitor usability, acceptability, and dropout rates, and compare symptom data with clinical scales. The main outcome is to determine the reliability of the app at 3 and 6 months. The study also examines whether women using contraception have different clinical outcomes. The total participation spans at least 6 months with ongoing assessments.
CONDITIONS
Brief Title
Enabling Women with Parkinson's Disease to Identify and Better Manage Hormonal Triggers of Parkinsonian Symptoms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Non-menopausal women
- Diagnosis of Parkinson's disease according to MDS criteria with symptoms onset at least two years before inclusion
- Age between 18 and 56 years
- On stable Parkinson's disease medication for at least two months with no planned changes in the next three months
- Women with or without oral contraceptive pills (OCP) or intrauterine devices (IUD)
You will not qualify if you...
- Post-menopausal women with Parkinson's disease
- Any condition that may prevent safe or successful completion of study procedures, such as dementia or severe depression
- Inability to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants use the MyMovesMatter mobile application to track changes in motor and non-motor symptoms during their hormonal cycles.
Continuous remote tracking via mobile application
Duration - Up to 6 months
Participants are monitored for symptom changes and the effects of clinical interventions suggested by neurologists based on app data.
Assessments at 3 months and 6 months
Trial Site Locations
Total: 4 locations
1
CHU Grenoble Alpes
Grenoble, Grenoble, France
Actively Recruiting
2
CHU Nantes Hôpital Laennec
Nantes, France, 44000
Actively Recruiting
3
CHU Rennes -Site Pontchaillou
Rennes, France, 35000
Actively Recruiting
4
Chu Toulouse
Toulouse, France, 31000
Actively Recruiting
Research Team
E
Elena MORO
P
PIERRE PELISSIER
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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