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

Parkinson Disease Clinical Trial

— EFN-VALID  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04455074
• Other study ID #: 38RC20.116
• Secondary ID: 2020-A00862-37
• Status: Completed
• Phase: N/A
• Start date: September 23, 2020
• Est. completion date: March 23, 2023

Study information

• Verified date: August 2023
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: March 23, 2023
• Est. primary completion date: March 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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, ...)

Related Conditions & MeSH terms

• Fluctuating Mood Symptoms
• Parkinson Disease

Intervention

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.

Locations

Country	Name	City	State
France	CHU Amiens	Amiens
France	CHU de Bordeaux-Hôpital Pellegrin	Bordeaux
France	CHU Clermont-Ferrand	Clermont-Ferrand
France	University hospital grenoble	Grenoble
France	Hospices Civils Lyon (HCL)	Lyon
France	CHRU Strasbourg	Strasbourg

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Grenoble	University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	validation of FN scale: realiability	EFN score	2 months
Primary	validation of FN scale: internal consistency	EFN score	4 hours
Primary	validation of FN scale: measurement error	test-retest	2 months
Primary	validation of FN scale: structural validity	EFN score	4 hours
Primary	validation of FN scale: responsiveness		4 hours
Primary	validation of FN scale: acceptability	EFN score	4 hours
Secondary	correlation of EFN scores with socio-clinical characteristics 1	MDS-UPDRS	4 hours
Secondary	correlation of EFN scores with socio-clinical characteristics 2	Severity of PD (Clinical Impression of Severity Index for PD - CISI-PD)	4 hours
Secondary	correlation of EFN scores with socio-clinical characteristics 3	stage of PD (Hoehn & Yahr stage)	4 hours
Secondary	correlation of EFN scores with socio-clinical characteristics (4)	cognitif state (Montreal cognitive assessment - MoCA test)	4 hours
Secondary	correlation of EFN scores with socio-clinical characteristics (5)	Impulsive-Compulsive Disorders (QUIP-RS)	4 hours
Secondary	correlation of EFN scores with socio-clinical characteristics (6)	Dopamine-dependant behavior (ACDD)	4 hours
Secondary	correlation of EFN scores with socio-clinical characteristics (7)	Wearing off (QUICK questionnaire)	4 hours
Secondary	correlation of EFN scores with socio-clinical characteristics (8)	Depression (Beck depression inventory BDI-II)	4 hours
Secondary	correlation of EFN scores with socio-clinical characteristics (9)	Evalulation of impulsive behavior (UPSS)	4 hours