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RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: University Hospital, Grenoble • ClinicalTrials.gov ID: NCT06582212

Registry updated: 2026-10-02
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Description

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.

Interventions

  • Mymovesmatter mobile application (Device)
    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

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.

Conditions

Digital Technology Mobile Application Motor Fluctuations Oestrogen Parkinson Disease

Locations

  • CHU Grenoble Alpes — Grenoble, France
  • CHU Nantes Hôpital Laennec — Nantes, France
  • CHU Rennes -Site Pontchaillou — Rennes, France
  • Chu Toulouse — Toulouse, France
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record