Enabling Women with Parkinson's Disease to Identify and Better Manage Hormonal Triggers of Parkinsonian Symptoms
Lady-PD
2 other identifiers
interventional
100
1 country
4
Brief Summary
Forty percent of people living worldwide with Parkinson's disease (PD) are women. Twenty percent of patients have PD onset under the age of 60 years, a time when women may encounter significant caregiving responsibilities along with occupational and other competing demands. Studies with surveys of women with PD (WwPD) have reported worsening of PDrelated symptoms especially in the week prior and the week of menses. However, prospective evidence is scarce and clinical guidelines to manage this issue do not exist. As a result, care is either non-existent or fragmented. The investigators propose a French multicentre prospective pilot study to capture changes in PD symptoms in relation to the stages of the menstrual cycle aiming at reducing hormonal related worsening in PD symptoms through neurologist intervention and/or patient selfmanagement. Digital technology will remotely enable patient reported outcome (PRO) tracking through the My Moves Matter app changes in PD symptoms during several months. This information will then help neurologists to customize treatment. Changes in motor symptoms will also be highlighted by tracking through the use of a wearable device (PDMonitor) to objectively detect motor changes together with the app. This will further support the reliability of the app. This study will provide evidence for the impact of the menstrual cycle on PD and help neurologists and patients to better manage PD symptoms related to these hormonal changes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2025
Typical duration for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 24, 2024
CompletedFirst Posted
Study publicly available on registry
September 3, 2024
CompletedStudy Start
First participant enrolled
March 12, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 12, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 12, 2027
March 25, 2025
March 1, 2025
2 years
June 24, 2024
March 24, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Reliability of the MyMovesMatter mobile application
Changes in PD symptoms collected during the menstrual/hormonal cycle versus those collected in the other days of the month. These changes will be evaluated using a linear system included in the My Moves Matter application. In particular, bradykinesia, tremor, gait, posture, dyskinesia, fatigue, anxiety, pain, urinary disturbances and sweating will be assessed.
Inclusion, 3 months and 6 months
Secondary Outcomes (4)
Subjective versus objective evaluation of Parkinson's disease symptoms
Inclusion, 3 months and 6 months
To determine the clinical efficacy of interventions
At 3 months and 6 months
To evaluate whether Woman with Parkinson's disease with and without contraception have different clinical outcomes
Inclusion, 3 months and 6 months
Usability of the system
At 6 months
Study Arms (1)
MyMovesMatter mobile application
EXPERIMENTALInterventions
Patients with Parkinson's disease will use a mobile application (Mymovesmatter) to evaluate changes in motor and non motor symptoms during their hormonal cycles.
Eligibility Criteria
You may qualify if:
- Non-menopausal women
- Age 18-56 years
- On stable medication regimen for PD for at least two months without foreseen need to modify it within the next three months
- With and without OCP or intrauterine devices (IUD
You may not qualify if:
- Post-menopausal women with PD
- Any condition that, in the opinion of the investigator, will preclude the participant from successfully or safely completing study procedures (i.e., dementia, severe depression, etc.)
- People not able to give an informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
CHU Grenoble Alpes
Grenoble, Grenoble, France
CHU Nantes Hôpital Laennec
Nantes, 44000, France
CHU Rennes -Site Pontchaillou
Rennes, 35000, France
Chu Toulouse
Toulouse, 31000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elena MORO
CHU Grenoble Alpes
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2024
First Posted
September 3, 2024
Study Start
March 12, 2025
Primary Completion (Estimated)
March 12, 2027
Study Completion (Estimated)
September 12, 2027
Last Updated
March 25, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share