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

NCT ID: NCT04455074

Last Updated: 2025-12-22

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-23

Study Completion Date

2023-03-23

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.

Conditions

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Parkinson Disease Fluctuating Mood Symptoms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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PD patients with motor fluctuations

FN scale is an autoquestionnaire consisting of 20 questions, to be answered in On-med and OFF-med condition

Group Type EXPERIMENTAL

FN scale auto-questionnaire

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

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, ...)
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Clermont-Ferrand

OTHER

Sponsor Role collaborator

University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elena MORO, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

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CHU Amiens

Amiens, , France

Site Status

CHU de Bordeaux-Hôpital Pellegrin

Bordeaux, , France

Site Status

CHU Clermont-Ferrand

Clermont-Ferrand, , France

Site Status

University hospital grenoble

Grenoble, , France

Site Status

Hospices Civils Lyon (HCL)

Lyon, , France

Site Status

CHRU Strasbourg

Strasbourg, , France

Site Status

Countries

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France

References

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Schmitt E, Bouvard M, Anheim M, Guehl D, Klinger H, Laurencin C, Marques A, Meissner WG, Thobois S, Thomas J, Tir M, Debu B, Moro E; NFS-VALID Study. Neuropsychiatric fluctuations in Parkinson's disease: A French multicenter study of the NFS psychometric properties. Parkinsonism Relat Disord. 2025 Sep;138:107954. doi: 10.1016/j.parkreldis.2025.107954. Epub 2025 Jul 11.

Reference Type RESULT
PMID: 40683099 (View on PubMed)

Other Identifiers

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2020-A00862-37

Identifier Type: OTHER

Identifier Source: secondary_id

38RC20.116

Identifier Type: -

Identifier Source: org_study_id