NCT04455074

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: All
• Age: 35 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Parkinson Disease
• Fluctuating Mood Symptoms

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-09-23
• Primary completion: 2023-03-23
• Completion: 2023-03-23
• First posted: 2020-07-02
• Last updated: 2025-12-22

Locations

6 sites across 1 country: France