Enabling Women with Parkinson's Disease to Identify and Better Manage Hormonal Triggers of Parkinsonian Symptoms

This is a prospective multicentre pilot study of the impact of the menstrual/hormonal cycle on PD symptoms and their treatment in pre-menopausal WwPD based on the remote tracking of PD symptoms and menstrual/hormonal cycle through the MMM digital health app in the French language.

There is an ongoing European preliminary study investigating the usability of the MMM App to track menstrual symptoms in WwPD, endorsed by the Parkinson's Disease Research Cluster in the University College Cork in Ireland.

The aim of that study does not overlap with the current proposal.

The aims of the LADY-PD project are:

• Aim 1. To determine the reliability of using our new mobile application to track motor and non-motor symptoms in pre-menopausal WwPD. French WwPD will use the My Moves Matter (MMM) application downloaded in their mobile phone to track their PD symptoms during their hormonal cycle. Changes during the cycle can be identified using a linear system to quantify changes in each symptom. The investigators will measure drop-out rate, missing data, usability, and acceptability (the latter with questionnaires for patients and neurologists).
• Aim 2. To compare the mobile application subjective motor data against the gold standard clinical scale, the motor part of the Movement Disorders Society Unified Parkinson Disease Rating Scale (MDS-UPDRS). This will be done acquiring data coming from a subset of WwPD who will have an objective measurement of the MDS-UPDRS (using the PDMonitor, a digital device able to measure bradykinesia, tremor, gait, posture, rigidity, dyskinesia) while using the mobile application.

Statistical analysis will compare data between the two devices.

• Aim 3. To determine the clinical efficacy of interventions (changes on medication, physiotherapy, et cetera) suggested by the neurologists to improve motor and nonmotor symptoms detected by the mobile application during the initial 3-month period of evaluation. Effects of pharmacological and non-pharmacological interventions will be measured using the mobile app after a 3-month period of evaluation.

The investigators hypothesize that

• pre-menopausal WwPD will experience a worsening of motor and NMS during their menstrual/hormonal cycle (and possibly independently by OCP treatment);
• these changes will have a relevant impact on the well-being of patients, and on their daily and social activities;
• appropriate management of these changes can effectively improve quality of life of pre-menopausal WwPD.

Inclusion criteria

• Non-menopausal women
• Diagnosis of PD according to the MDS criteria onset of PD symptoms since at least two years before inclusion
• 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

Exclusion criteria

• 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.