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

Not Applicable

Completed

• Conditions: Fluctuating Mood Symptoms; Parkinson Disease
• Interventions: Other: FN scale auto-questionnaire

• Registration Number: NCT04455074
• Lead Sponsor: University Hospital, Grenoble

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2020-04-23
• Study First Submitted QC: 2020-06-29
• Study First Posted: 2020-07-02
• Study Start: 2020-09-23
• Primary Completion: 2023-03-23
• Study Completion: 2023-03-23
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-01
• Last Update Posted: 2023-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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, ...)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PD patients with motor fluctuations	FN scale auto-questionnaire	FN scale is an autoquestionnaire consisting of 20 questions, to be answered in On-med and OFF-med condition

Primary Outcome Measures

Name	Time	Method
validation of FN scale: realiability	2 months	EFN score
validation of FN scale: internal consistency	4 hours	EFN score
validation of FN scale: measurement error	2 months	test-retest
validation of FN scale: responsiveness	4 hours
validation of FN scale: structural validity	4 hours	EFN score
validation of FN scale: acceptability	4 hours	EFN score

Secondary Outcome Measures

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

Trial Locations

Locations (6)

CHRU Strasbourg; 🇫🇷 Strasbourg, France

CHU Amiens; 🇫🇷 Amiens, France

CHU de Bordeaux-Hôpital Pellegrin; 🇫🇷 Bordeaux, France

Hospices Civils Lyon (HCL); 🇫🇷 Lyon, France

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

University hospital grenoble; 🇫🇷 Grenoble, France