Study of the Test-retest Reliability of the Neuropsychiatric Fluctuations Scale in Parkinson's Disease
NCT ID: NCT06701955
Last Updated: 2025-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2025-02-01
2027-03-01
Brief Summary
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Detailed Description
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Due to the lack of specific tools for assessing NPF, our team developed a 20-item self-questionnaire specifically evaluating NPF in acute phases: the Neuropsychological Fluctuations Scale (NFS), which was first published in Movement Disorders, Clinical Practice (Schmitt et al., 2018). Recently, we studied the psychometric properties of the NFS in two populations of Parkinson's disease patients and in the general population (EFN Pre-Validation and EFN-Validation studies: ClinicalTrials.gov NCT04455074). The results regarding internal consistency, sensitivity, and specificity of the NFS, as well as its internal structure and external validity, were published in Frontiers in Neurology in 2023 (Schmitt et al., 2023). It has been demonstrated that the NFS is an innovative tool that complements existing motor and non-motor evaluations, and its utility in diagnosing and managing NPF is significant.
In order to finalize the validation of the NFS and further understand its psychometric characteristics, assessing the temporal stability of the NFS through test-retest reliability is an essential step.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
OTHER
NONE
Study Groups
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sequence of intervention
self administered questionnaires at different time points..
Questionnaire and Physical Exam
self administered questionnaires
Interventions
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Questionnaire and Physical Exam
self administered questionnaires
Eligibility Criteria
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Inclusion Criteria
* Idiopathic Parkinson's disease (according to the criteria of the Movement Disorders Society)
* Presence of motor fluctuations described by the patient, their relatives, or identified by the clinician
* Stability of antiparkinsonian treatment for at least one month
* Mastery of the French language
* Able to give consent.
* Affiliated to the social security system
Exclusion Criteria
* Dementia (MoCa \< 23)
* No antiparkinsonian treatment or treatment modified for less than one month
* Persons referred to in Articles L1121-5 to L1121-8 of the CSP (corresponds to all protected persons: pregnant women, parturients, breastfeeding mothers, persons deprived of liberty by judicial or administrative decision, persons receiving psychiatric care under Articles L. 3212-1 and L. 3213-1 who are not covered by the provisions of Article L. 1121-8, persons admitted to a health or social establishment for purposes other than research, minors, persons subject to a legal protection measure or unable to express their consent))
* Subject in a period of exclusion from another interventional study.
30 Years
75 Years
ALL
No
Sponsors
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University Hospital, Grenoble
OTHER
Responsible Party
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Locations
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CHUGA
Grenoble, , France
Countries
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Central Contacts
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Facility Contacts
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Emmanuelle SCHMITT
Role: primary
Andréa KISTNER
Role: backup
Other Identifiers
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2024-A01403-44
Identifier Type: OTHER
Identifier Source: secondary_id
38RC24.0196
Identifier Type: -
Identifier Source: org_study_id
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