Study of the Test-retest Reliability of the Neuropsychiatric Fluctuations Scale in Parkinson's Disease (EFN-RETEST)
Study of the Test-retest Reliability of the Neuropsychiatric Fluctuations Scale (EFN)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
During the progression of Parkinson's disease, a large number of patients experience fluctuations in motor status associated with neuropsychiatric fluctuations (NPF) (alternating episodes of depression, anxiety, and apathy with hypomanic states, impulsivity, and attention disorders). NPF may have a significant impact on patients' quality of life as well as on that of their caregivers. Moreover, the presence of these fluctuations is a risk factor for the development of self-medication behaviors, which can lead to addiction to antiparkinsonian treatments.
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Andrea Kistner
- Email: akistner@chu-grenoble.fr
Study Contact Backup
- Name: Emmanuelle Schmitt, PHD
- Phone Number: +33 4 76765791
- Email: eschmitt@chu-grenoble.fr
Study Locations
-
-
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Grenoble, France
- Recruiting
- CHUGA
-
Contact:
- Emmanuelle SCHMITT
-
Contact:
- Andréa KISTNER
-
Principal Investigator:
- Emmanuelle SCHMITT
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Age > 30 and ≤ 75 years
- 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:
Parkinsonian syndrome other than idiopathic Parkinson's disease
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: sequence of intervention
self administered questionnaires at different time points..
|
self administered questionnaires
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
validation of test-retest reliabililty
Time Frame: 4 weeks
|
validation of test-retest reliabililty of the neuropsychiatric fluctuations scale
|
4 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 38RC24.0196
- 2024-A01403-44 (Other Identifier: ID RCB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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