Clinical trial NCT04455074: Validation of the Neuropsychiatric Fluctuations Scale (EFN-VALID))
Official title: French Validation Study of a New Scale for Neuropsychiatric Fluctuations in Parkinson Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Fluctuating Mood Symptoms
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: University Hospital, Clermont-Ferrand
First posted: 2020-07-02
Enrollment: 130
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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, ...)

Primary outcomes:
measure: validation of FN scale: realiability
timeFrame: 2 months
measure: validation of FN scale: internal consistency
timeFrame: 4 hours
measure: validation of FN scale: measurement error
timeFrame: 2 months
measure: validation of FN scale: structural validity
timeFrame: 4 hours
measure: validation of FN scale: responsiveness
timeFrame: 4 hours
measure: validation of FN scale: acceptability
timeFrame: 4 hours
Secondary outcomes:
measure: correlation of EFN scores with socio-clinical characteristics 1
timeFrame: 4 hours
measure: correlation of EFN scores with socio-clinical characteristics 2
timeFrame: 4 hours
measure: correlation of EFN scores with socio-clinical characteristics 3
timeFrame: 4 hours
measure: correlation of EFN scores with socio-clinical characteristics (4)
timeFrame: 4 hours
measure: correlation of EFN scores with socio-clinical characteristics (5)
timeFrame: 4 hours
measure: correlation of EFN scores with socio-clinical characteristics (6)
timeFrame: 4 hours
measure: correlation of EFN scores with socio-clinical characteristics (7)
timeFrame: 4 hours
measure: correlation of EFN scores with socio-clinical characteristics (8)
timeFrame: 4 hours
measure: correlation of EFN scores with socio-clinical characteristics (9)
timeFrame: 4 hours
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
city: Bordeaux
country: France
facility: CHU de Bordeaux-Hôpital Pellegrin
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
city: Grenoble
country: France
facility: University hospital grenoble
city: Lyon
country: France
facility: Hospices Civils Lyon (HCL)
city: Strasbourg
country: France
facility: CHRU Strasbourg
Study officials:
affiliation: University Hospital, Grenoble
name: Elena MORO, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: