RecruitingNot ApplicableNCT06582212

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

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


Sponsor

University Hospital, Grenoble

Enrollment

100 participants

Start Date

Mar 12, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 56 Years

Inclusion Criteria5

  • 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 Criteria3

  • 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.

Interventions

DEVICEMymovesmatter mobile application

Patients with Parkinson's disease will use a mobile application (Mymovesmatter) to evaluate changes in motor and non motor symptoms during their hormonal cycles.


Locations(4)

CHU Grenoble Alpes

Grenoble, Grenoble, France

CHU Nantes Hôpital Laennec

Nantes, France

CHU Rennes -Site Pontchaillou

Rennes, France

Chu Toulouse

Toulouse, France

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NCT06582212


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