Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06582212
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-06-24
Brief Title:
Enabling Women with Parkinsons Disease to Identify and Better Manage Hormonal Triggers of Parkinsonian Symptoms
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Enabling Women with Parkinsons Disease to Identify and Better Manage Hormonal Triggers
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Lady-PD
Brief Summary:
Forty percent of people living worldwide with Parkinsons 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 andor 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
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 andor 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
Detailed Description:
This is a prospective multicentre pilot study of the impact of the menstrualhormonal cycle on PD symptoms and their treatment in pre-menopausal WwPD based on the remote tracking of PD symptoms and menstrualhormonal 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 Parkinsons 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
1 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
2 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
3 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
1 pre-menopausal WwPD will experience a worsening of motor and NMS during their menstrualhormonal cycle and possibly independently by OCP treatment
2 these changes will have a relevant impact on the well-being of patients and on their daily and social activities
3 appropriate management of these changes can effectively improve quality of life of pre-menopausal WwPD
There is an ongoing European preliminary study investigating the usability of the MMM App to track menstrual symptoms in WwPD endorsed by the Parkinsons 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
1 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
2 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
3 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
1 pre-menopausal WwPD will experience a worsening of motor and NMS during their menstrualhormonal cycle and possibly independently by OCP treatment
2 these changes will have a relevant impact on the well-being of patients and on their daily and social activities
3 appropriate management of these changes can effectively improve quality of life of pre-menopausal WwPD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None