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

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

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.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease; Fluctuating Mood Symptoms
• Intervention / Treatment: Other: FN scale auto-questionnaire

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 Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elena MORO, MD PhD; Phone Number: 33 (0)4 7676 5791; Email: emoro@chu-grenoble.fr
• Study Contact Backup: Name: Emmanuelle SCHMITT; Email: eschmitt@chu-grenoble.fr

Study Locations

• France
  • Amiens, France, 80 054
    • CHU Amiens
  • Bordeaux, France, 33 076
    • CHU de Bordeaux-Hopital Pellegrin
  • Clermont-Ferrand, France, 63003
    • CHU Clermont-Ferrand
  • Grenoble, France, 38043
    • University Hospital Grenoble
  • Lyon, France, 69 677
    • Hospices Civils Lyon (HCL)
  • Strasbourg, France, 67091
    • CHRU Strasbourg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PD patients with motor fluctuations; FN scale is an autoquestionnaire consisting of 20 questions, to be answered in On-med and OFF-med condition	Other: FN scale auto-questionnaire; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Collaborators: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Elena MORO, MD PhD, University Hospital, Grenoble

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2020
• Primary Completion (Actual): March 23, 2023
• Study Completion (Actual): March 23, 2023

Study Registration Dates

• First Submitted: April 23, 2020
• First Submitted That Met QC Criteria: June 29, 2020
• First Posted (Actual): July 2, 2020

Study Record Updates

• Last Update Posted (Actual): August 2, 2023
• Last Update Submitted That Met QC Criteria: August 1, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 38RC20.116; 2020-A00862-37 (Other Identifier: ID RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No