Clinical trial NCT06582212: Enabling Women with Parkinson's Disease to Identify and Better Manage Hormonal Triggers of Parkinsonian Symptoms
Official title: Enabling Women with Parkinson's Disease to Identify and Better Manage Hormonal Triggers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Digital Technology
Mobile Application
Motor Fluctuations
Oestrogen
Parkinson Disease
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2024-09-03
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 56
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Detailed description: 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:

1. 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).
2. 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.
3. 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

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

Eligibility criteria: 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.

Primary outcomes:
measure: Reliability of the MyMovesMatter mobile application
timeFrame: Inclusion, 3 months and 6 months
Secondary outcomes:
measure: Subjective versus objective evaluation of Parkinson's disease symptoms
timeFrame: Inclusion, 3 months and 6 months
measure: To determine the clinical efficacy of interventions
timeFrame: At 3 months and 6 months
measure: To evaluate whether Woman with Parkinson's disease with and without contraception have different clinical outcomes
timeFrame: Inclusion, 3 months and 6 months
measure: Usability of the system
timeFrame: At 6 months
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHU Grenoble Alpes
city: Nantes
country: France
facility: CHU Nantes Hôpital Laennec
city: Rennes
country: France
facility: CHU Rennes -Site Pontchaillou
city: Toulouse
country: France
facility: Chu Toulouse
Study officials:
affiliation: CHU Grenoble Alpes
name: Elena MORO
role: PRINCIPAL_INVESTIGATOR
References: