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NCT Number: NCT04455074

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

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Fluctuating Mood Symptoms Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Amiens, Amiens, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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, ...)

Treatment and study plan

FN scale auto-questionnaire

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.

Primary outcomes

  1. validation of FN scale: realiability

    Time frame: 2 months

    EFN score

  2. validation of FN scale: internal consistency

    Time frame: 4 hours

    EFN score

  3. validation of FN scale: measurement error

    Time frame: 2 months

    test-retest

  4. validation of FN scale: structural validity

    Time frame: 4 hours

    EFN score

  5. validation of FN scale: responsiveness

    Time frame: 4 hours

  6. validation of FN scale: acceptability

    Time frame: 4 hours

    EFN score

Secondary outcomes

  1. correlation of EFN scores with socio-clinical characteristics 1

    Time frame: 4 hours

    MDS-UPDRS

  2. correlation of EFN scores with socio-clinical characteristics 2

    Time frame: 4 hours

    Severity of PD (Clinical Impression of Severity Index for PD - CISI-PD)

  3. correlation of EFN scores with socio-clinical characteristics 3

    Time frame: 4 hours

    stage of PD (Hoehn & Yahr stage)

  4. correlation of EFN scores with socio-clinical characteristics (4)

    Time frame: 4 hours

    cognitif state (Montreal cognitive assessment - MoCA test)

  5. correlation of EFN scores with socio-clinical characteristics (5)

    Time frame: 4 hours

    Impulsive-Compulsive Disorders (QUIP-RS)

  6. correlation of EFN scores with socio-clinical characteristics (6)

    Time frame: 4 hours

    Dopamine-dependant behavior (ACDD)

  7. correlation of EFN scores with socio-clinical characteristics (7)

    Time frame: 4 hours

    Wearing off (QUICK questionnaire)

  8. correlation of EFN scores with socio-clinical characteristics (8)

    Time frame: 4 hours

    Depression (Beck depression inventory BDI-II)

  9. correlation of EFN scores with socio-clinical characteristics (9)

    Time frame: 4 hours

    Evalulation of impulsive behavior (UPSS)

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

  • University Hospital, Clermont-Ferrand

Registry information

Official study title

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

Acronym: EFN-VALID

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jul 2, 2020
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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