Actively Recruiting

Phase Not Applicable
Age: 18Years - 56Years
FEMALE
NCT06582212

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

Led by University Hospital, Grenoble · Updated on 2025-03-25

100

Participants Needed

4

Research Sites

130 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 56Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Non-menopausal women
  • Diagnosis of Parkinson's disease according to MDS criteria with symptom onset at least two years ago
  • Age between 18 and 56 years
  • Stable Parkinson's medication regimen for at least two months without planned changes in the next three months
  • Use or non-use of oral contraceptive pills or intrauterine devices
Not Eligible

You will not qualify if you...

  • Post-menopausal women with Parkinson's disease
  • Conditions preventing safe or successful study participation (e.g., dementia, severe depression)
  • Unable to give informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

CHU Grenoble Alpes

Grenoble, Grenoble, France

Actively Recruiting

2

CHU Nantes Hôpital Laennec

Nantes, France, 44000

Actively Recruiting

3

CHU Rennes -Site Pontchaillou

Rennes, France, 35000

Actively Recruiting

4

Chu Toulouse

Toulouse, France, 31000

Actively Recruiting

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Research Team

E

Elena MORO

CONTACT

P

PIERRE PELISSIER

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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