Validation of the Neuropsychiatric Fluctuations Scale (EFN-VALID))

Study Overview
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Brief Summary
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Neuropsychiatric fluctuations (NF) are among the most disabling non motor fluctuations in Parkinson disease (PD). The investigators developed the NF-scale for acute assessment of non-motor neuropsychiatric fluctuations between the off- and on-medication conditions in PD. The main goal of this project is to validate the NF-scale in french language in a multicenter approach.

Detailed Description
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Anxiety, sadness, lack of energy and motivation, fatigue and pain are common during the off-medication condition, whereas euphoria, well-being, impulse control disorders, behavioral addictions, mania, and psychosis might occur during the on-medication condition. Early diagnosis of NpsyF is crucial for their holistic management. Unfortunately, NpsyF are often under-recognized by patients or misdiagnosed by physicians due to the lack of specific assessment tools. The NFS is composed of 20 items among which ten measure the ON neuropsychological state and ten, the OFF neuropsychological state. It provides two sub-scores (one ON and one OFF) with a maximal total score of 30.

Official Title
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French Validation Study of a New Scale for Neuropsychiatric Fluctuations in Parkinson Disease

Conditions
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Parkinson Disease, Fluctuating Mood Symptoms

Intervention / Treatment
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* Other: FN scale auto-questionnaire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Idiopathic Parkinson's disease presence of motor fluctuations, requiring a levodopa test french native speaker Exclusion Criteria: Dementia (MoCa < 24) Parkinson syndrome other than idiopathic PD people excluded according to french law (including pregnant women or nursing mothers, ...)

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PD patients with motor fluctuations<br>FN scale is an autoquestionnaire consisting of 20 questions, to be answered in On-med and OFF-med condition | Other: FN scale auto-questionnaire<br>* Patients will be asked to fill in the NF scale questionnaire together with other tests and rating scales, during a routine L-Dopa test, in 2 conditions: OFF-med and ON-med.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| validation of FN scale: realiability | EFN score | 2 months | 
| validation of FN scale: internal consistency | EFN score | 4 hours | 
| validation of FN scale: measurement error | test-retest | 2 months | 
| validation of FN scale: structural validity | EFN score | 4 hours | 
| validation of FN scale: responsiveness |  | 4 hours | 
| validation of FN scale: acceptability | EFN score | 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation of EFN scores with socio-clinical characteristics 1 | MDS-UPDRS | 4 hours | 
| correlation of EFN scores with socio-clinical characteristics 2 | Severity of PD (Clinical Impression of Severity Index for PD - CISI-PD) | 4 hours | 
| correlation of EFN scores with socio-clinical characteristics 3 | stage of PD (Hoehn & Yahr stage) | 4 hours | 
| correlation of EFN scores with socio-clinical characteristics (4) | cognitif state (Montreal cognitive assessment - MoCA test) | 4 hours | 
| correlation of EFN scores with socio-clinical characteristics (5) | Impulsive-Compulsive Disorders (QUIP-RS) | 4 hours | 
| correlation of EFN scores with socio-clinical characteristics (6) | Dopamine-dependant behavior (ACDD) | 4 hours | 
| correlation of EFN scores with socio-clinical characteristics (7) | Wearing off (QUICK questionnaire) | 4 hours | 
| correlation of EFN scores with socio-clinical characteristics (8) | Depression (Beck depression inventory BDI-II) | 4 hours | 
| correlation of EFN scores with socio-clinical characteristics (9) | Evalulation of impulsive behavior (UPSS) | 4 hours |