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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 56
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
CHU Grenoble Alpes
RECRUITING
Grenoble
CHU Nantes Hôpital Laennec
RECRUITING
Nantes
CHU Rennes -Site Pontchaillou
RECRUITING
Rennes
Chu Toulouse
RECRUITING
Toulouse
Contact Information
Primary
Elena MORO
emoro@chu-grenoble.fr
0476769452
Backup
PIERRE PELISSIER
ppelissier@chu-grenoble.fr
0476769459
Time Frame
Start Date: 2025-03-12
Estimated Completion Date: 2027-09-12
Participants
Target number of participants: 100
Treatments
Experimental: MyMovesMatter mobile application
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Grenoble

This content was sourced from clinicaltrials.gov