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

Plain Language Summary

Simplified for easier understanding

This study investigates how hormonal changes during the menstrual cycle affect Parkinson's disease symptoms in women. Many women with Parkinson's report that their symptoms worsen at certain points in their cycle. This trial will track symptoms and hormone levels over time to identify these patterns. **You may be eligible if...** - You are a woman between 18 and 56 years old who still has menstrual cycles (not yet menopausal) - You have been diagnosed with Parkinson's disease for at least 2 years - Your Parkinson's medication has been stable for at least 2 months **You may NOT be eligible if...** - You are post-menopausal - You have had a hysterectomy or both ovaries removed - You have had deep brain stimulation (DBS) surgery - You have significant cognitive impairment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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