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

Last updated: March 24, 2025
Sponsor: University Hospital, Grenoble
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Mymovesmatter mobile application

Clinical Study ID

NCT06582212
38RC24.0082
2024-A00598-39
  • Ages 18-56
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Non-menopausal women

  • Diagnosis of PD according to the MDS criteria onset of PD symptoms since at leasttwo years before inclusion

  • Age 18-56 years

  • On stable medication regimen for PD for at least two months without foreseen need tomodify it within the next three months

  • With and without OCP or intrauterine devices (IUD

Exclusion

Exclusion Criteria:

  • Post-menopausal women with PD

  • Any condition that, in the opinion of the investigator, will preclude theparticipant from successfully or safely completing study procedures (i.e., dementia,severe depression, etc.)

  • People not able to give an informed consent.

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Mymovesmatter mobile application
Phase:
Study Start date:
March 12, 2025
Estimated Completion Date:
September 12, 2027

Study 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.

Connect with a study center

  • CHU Grenoble Alpes

    Grenoble,
    France

    Active - Recruiting

  • CHU Nantes Hôpital Laennec

    Nantes, 44000
    France

    Active - Recruiting

  • CHU Rennes -Site Pontchaillou

    Rennes, 35000
    France

    Active - Recruiting

  • Chu Toulouse

    Toulouse, 31000
    France

    Active - Recruiting

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