Enabling Women with Parkinson's Disease to Identify and Better Manage Hormonal Triggers of Parkinsonian Symptoms
NCT Number: NCT06582212
Acronym: Lady-PD
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Digital Technology|Mobile Application|Motor Fluctuations|Oestrogen|Parkinson Disease
Sponsor: University Hospital, Grenoble
Sex: FEMALE
Age: ADULT
Enrollment: 100
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-09
Completion Date: 2027-09

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.

Primary Outcome Measures: Reliability of the MyMovesMatter mobile application, Changes in PD symptoms collected during the menstrual/hormonal cycle versus those collected in the other days of the month. These changes will be evaluated using a linear system included in the My Moves Matter application. In particular, bradykinesia, tremor, gait, posture, dyskinesia, fatigue, anxiety, pain, urinary disturbances and sweating will be assessed., Inclusion, 3 months and 6 months
Secondary Outcome Measures: Subjective versus objective evaluation of Parkinson's disease symptoms, Subjective motor variables obtained with the mobile application will be compared to the the gold standard clinical scale, the related items Movement Disorders Society -Unified Parkinson Disease Rating Scale part III (0-132) and IV (0-24). Lower scores mean a better outcome., Inclusion, 3 months and 6 months|To determine the clinical efficacy of interventions, Clinical efficacy of interventions suggested by the neurologists to improve motor and non-motor symptoms detected by the mobile application during the initial 3-month period of evaluation will be evaluated by analysing the scores' differences between T1 and T2 using the My Moves Matter application., At 3 months and 6 months|To evaluate whether Woman with Parkinson's disease with and without contraception have different clinical outcomes, To evaluate whether Woman with Parkinson's disease with and without contraception have different clinical outcomes.

The total sample will be divided into two sub-groups (with vs. without contraception) and the effect of Period will be compared between the two sub-groups using ANOVA (GLM) for repeated measures, with Group as an inter-subjects' factor and Period as an intra-subject factor., Inclusion, 3 months and 6 months|Usability of the system, Usability of the system will be examined using the System Usability Scale score (max 100) averaged across participants. Higher scores mean better outcome., At 6 months