Enabling Women With Parkinson's Disease to Identify and Better Manage Hormonal Triggers of Parkinsonian Symptoms (Lady-PD)
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.
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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:
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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).
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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.
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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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Elena MORO
- Número de teléfono: 0476769452
- Correo electrónico: emoro@chu-grenoble.fr
Copia de seguridad de contactos de estudio
- Nombre: PIERRE PELISSIER
- Número de teléfono: 0476769459
- Correo electrónico: ppelissier@chu-grenoble.fr
Ubicaciones de estudio
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Grenoble, Francia
- Reclutamiento
- CHU Grenoble Alpes
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Contacto:
- ELENA MORO
- Correo electrónico: emoro@chu-grenoble.fr
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Contacto:
- Pierre PELISSIER
- Número de teléfono: 0476769452
- Correo electrónico: ppelissier@chu-grenoble.fr
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Nantes, Francia, 44000
- Reclutamiento
- CHU Nantes Hôpital Laennec
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Contacto:
- Philippe DAMIER, Pr
- Número de teléfono: 33 (0)2.40.16.52.12
- Correo electrónico: philippe.damier@chu-nantes.fr
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Contacto:
- Régis FRENAIS
- Número de teléfono: 33 (0)2 44 76 87 57
- Correo electrónico: regis.frenais@chu-nantes.fr
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Rennes, Francia, 35000
- Reclutamiento
- CHU Rennes -Site Pontchaillou
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Contacto:
- Sophie DRAPIER, PH
- Número de teléfono: +33 2 99 28 42 93
- Correo electrónico: Sophie.Drapier@chu-rennes.fr
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Contacto:
- Françoise KESTENS
- Número de teléfono: 33 (0)2 99 28 93 34
- Correo electrónico: ide recherche neuro PPEV <ide.recherche.neuro.PPEV@chu-rennes.fr>
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Toulouse, Francia, 31000
- Reclutamiento
- Chu Toulouse
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Contacto:
- Estelle HARROCH
- Número de teléfono: +33 5 61 77 55 41
- Correo electrónico: harroch.e@chu-toulouse.fr
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Contacto:
- Christine BREFEL-COURBON, PH
- Número de teléfono: 33 (0)5 61 14 59 62
- Correo electrónico: christine.brefel-courbon@univ-tlse3.fr
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Aplicación móvil MyMovesMatter
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Patients with Parkinson's disease will use a mobile application (Mymovesmatter) to evaluate changes in motor and non motor symptoms during their hormonal cycles. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Reliability of the MyMovesMatter mobile application
Periodo de tiempo: Inclusion, 3 months and 6 months
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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
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Subjective versus objective evaluation of Parkinson's disease symptoms
Periodo de tiempo: Inclusion, 3 months and 6 months
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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
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To determine the clinical efficacy of interventions
Periodo de tiempo: At 3 months and 6 months
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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
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To evaluate whether Woman with Parkinson's disease with and without contraception have different clinical outcomes
Periodo de tiempo: Inclusion, 3 months and 6 months
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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
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Usability of the system
Periodo de tiempo: At 6 months
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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
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Elena MORO, CHU Grenoble Alpes
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 38RC24.0082
- 2024-A00598-39 (Otro identificador: ID RCB)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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