Digital TechnologyLady-PDNCT06582212
Enabling Women With Parkinson's Disease to Identify and Better Manage Hormonal Triggers of Parkinsonian Symptoms
A study testing Mymovesmatter mobile application in people with Digital Technology and Mobile Application, run by University Hospital, Grenoble at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 56 years, women only
- Conditions the study is for
- Digital Technology, Mobile Application, Motor Fluctuations
- What is being tested?
- Mymovesmatter mobile application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 4 sitesFrance
- Study dates
- 12 Mar 2025to 12 Sep 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 56 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Recruiting
CHU Grenoble Alpes
Grenoble
ELENA MORO, emoro@chu-grenoble.fr
Pierre PELISSIER, 0476769452, ppelissier@chu-grenoble.fr
- Recruiting
CHU Nantes Hôpital Laennec
Nantes, 44000
Philippe DAMIER, Pr, 33 (0)2.40.16.52.12, philippe.damier@chu-nantes.fr
Régis FRENAIS, 33 (0)2 44 76 87 57, regis.frenais@chu-nantes.fr
- Recruiting
CHU Rennes -Site Pontchaillou
Rennes, 35000
Sophie DRAPIER, PH, +33 2 99 28 42 93, Sophie.Drapier@chu-rennes.fr
Françoise KESTENS, 33 (0)2 99 28 93 34, ide recherche neuro PPEV <ide.recherche.neuro.PPEV@chu-rennes.fr>
- Recruiting
Chu Toulouse
Toulouse, 31000
Christine BREFEL-COURBON, PH, 33 (0)5 61 14 59 62, christine.brefel-courbon@univ-tlse3.fr
Estelle HARROCH, +33 5 61 77 55 41, harroch.e@chu-toulouse.fr
About this study
Official title: Enabling Women With Parkinson's Disease to Identify and Better Manage Hormonal Triggers
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.
Read more
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.
Read the detailed description
This is a prospective multicentre pilot study of the impact of the menstrual/hormonal cycle on PD symptoms and their treatment in pre-menopausal WwPD based on the remote tracking of PD symptoms and menstrual/hormonal cycle through the MMM digital health app in the French language.
There is an ongoing European preliminary study investigating the usability of the MMM App to track menstrual symptoms in WwPD, endorsed by the Parkinson's Disease Research Cluster in the University College Cork in Ireland.
The aim of that study does not overlap with the current proposal.
The aims of the LADY-PD project are:
- Aim 1. To determine the reliability of using our new mobile application to track motor and non-motor symptoms in pre-menopausal WwPD. French WwPD will use the My Moves Matter (MMM) application downloaded in their mobile phone to track their PD symptoms during their hormonal cycle. Changes during the cycle can be identified using a linear system to quantify changes in each symptom. The investigators will measure drop-out rate, missing data, usability, and acceptability (the latter with questionnaires for patients and neurologists).
- Aim 2. To compare the mobile application subjective motor data against the gold standard clinical scale, the motor part of the Movement Disorders Society Unified Parkinson Disease Rating Scale (MDS-UPDRS). This will be done acquiring data coming from a subset of WwPD who will have an objective measurement of the MDS-UPDRS (using the PDMonitor, a digital device able to measure bradykinesia, tremor, gait, posture, rigidity, dyskinesia) while using the mobile application. Statistical analysis will compare data between the two devices.
- Aim 3. To determine the clinical efficacy of interventions (changes on medication, physiotherapy, et cetera) suggested by the neurologists to improve motor and nonmotor symptoms detected by the mobile application during the initial 3-month period of evaluation. Effects of pharmacological and non-pharmacological interventions will be measured using the mobile app after a 3-month period of evaluation.
The investigators hypothesize that
- pre-menopausal WwPD will experience a worsening of motor and NMS during their menstrual/hormonal cycle (and possibly independently by OCP treatment);
- these changes will have a relevant impact on the well-being of patients, and on their daily and social activities;
- appropriate management of these changes can effectively improve quality of life of pre-menopausal WwPD.
- Being tested
- Mymovesmatter mobile application
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mymovesmatter mobile applicationDevice
Patients with Parkinson's disease will use a mobile application (Mymovesmatter) to evaluate changes in motor and non motor symptoms during their hormonal cycles.
| Study group | Role | What they receive |
|---|---|---|
| MyMovesMatter mobile application | Experimental | Not described Receives: Device: Mymovesmatter mobile application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Inclusion, 3 months and 6 months
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start12 Mar 2025
- Primary completion12 Mar 2027 (estimated)
- Study completion12 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digital TechnologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elena MORO, Principal investigator, CHU Grenoble Alpes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06582212
- Sponsor's protocol ID
- 38RC24.0082
- Other IDs
- 2024-A00598-39
- Acronym
- Lady-PD
- Status last verified
- Sep 2026
- First submitted
- 24 Jun 2024
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No