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

Primary Purpose

Parkinson Disease, Fluctuating Mood Symptoms

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
FN scale auto-questionnaire
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Parkinson Disease

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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, ...)

Sites / Locations

  • CHU Amiens
  • CHU de Bordeaux-Hôpital Pellegrin
  • CHU Clermont-Ferrand
  • University hospital grenoble
  • Hospices Civils Lyon (HCL)
  • CHRU Strasbourg

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PD patients with motor fluctuations

Arm Description

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

Outcomes

Primary Outcome Measures

validation of FN scale: realiability
EFN score
validation of FN scale: internal consistency
EFN score
validation of FN scale: measurement error
test-retest
validation of FN scale: structural validity
EFN score
validation of FN scale: responsiveness
validation of FN scale: acceptability
EFN score

Secondary Outcome Measures

correlation of EFN scores with socio-clinical characteristics 1
MDS-UPDRS
correlation of EFN scores with socio-clinical characteristics 2
Severity of PD (Clinical Impression of Severity Index for PD - CISI-PD)
correlation of EFN scores with socio-clinical characteristics 3
stage of PD (Hoehn & Yahr stage)
correlation of EFN scores with socio-clinical characteristics (4)
cognitif state (Montreal cognitive assessment - MoCA test)
correlation of EFN scores with socio-clinical characteristics (5)
Impulsive-Compulsive Disorders (QUIP-RS)
correlation of EFN scores with socio-clinical characteristics (6)
Dopamine-dependant behavior (ACDD)
correlation of EFN scores with socio-clinical characteristics (7)
Wearing off (QUICK questionnaire)
correlation of EFN scores with socio-clinical characteristics (8)
Depression (Beck depression inventory BDI-II)
correlation of EFN scores with socio-clinical characteristics (9)
Evalulation of impulsive behavior (UPSS)

Full Information

First Posted
April 23, 2020
Last Updated
August 1, 2023
Sponsor
University Hospital, Grenoble
Collaborators
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT04455074
Brief Title
Validation of the Neuropsychiatric Fluctuations Scale (EFN-VALID))
Acronym
EFN-VALID
Official Title
French Validation Study of a New Scale for Neuropsychiatric Fluctuations in Parkinson Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
September 23, 2020 (Actual)
Primary Completion Date
March 23, 2023 (Actual)
Study Completion Date
March 23, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
Collaborators
University Hospital, Clermont-Ferrand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Fluctuating Mood Symptoms

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PD patients with motor fluctuations
Arm Type
Experimental
Arm Description
FN scale is an autoquestionnaire consisting of 20 questions, to be answered in On-med and OFF-med condition
Intervention Type
Other
Intervention Name(s)
FN scale auto-questionnaire
Intervention Description
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 Outcome Measure Information:
Title
validation of FN scale: realiability
Description
EFN score
Time Frame
2 months
Title
validation of FN scale: internal consistency
Description
EFN score
Time Frame
4 hours
Title
validation of FN scale: measurement error
Description
test-retest
Time Frame
2 months
Title
validation of FN scale: structural validity
Description
EFN score
Time Frame
4 hours
Title
validation of FN scale: responsiveness
Time Frame
4 hours
Title
validation of FN scale: acceptability
Description
EFN score
Time Frame
4 hours
Secondary Outcome Measure Information:
Title
correlation of EFN scores with socio-clinical characteristics 1
Description
MDS-UPDRS
Time Frame
4 hours
Title
correlation of EFN scores with socio-clinical characteristics 2
Description
Severity of PD (Clinical Impression of Severity Index for PD - CISI-PD)
Time Frame
4 hours
Title
correlation of EFN scores with socio-clinical characteristics 3
Description
stage of PD (Hoehn & Yahr stage)
Time Frame
4 hours
Title
correlation of EFN scores with socio-clinical characteristics (4)
Description
cognitif state (Montreal cognitive assessment - MoCA test)
Time Frame
4 hours
Title
correlation of EFN scores with socio-clinical characteristics (5)
Description
Impulsive-Compulsive Disorders (QUIP-RS)
Time Frame
4 hours
Title
correlation of EFN scores with socio-clinical characteristics (6)
Description
Dopamine-dependant behavior (ACDD)
Time Frame
4 hours
Title
correlation of EFN scores with socio-clinical characteristics (7)
Description
Wearing off (QUICK questionnaire)
Time Frame
4 hours
Title
correlation of EFN scores with socio-clinical characteristics (8)
Description
Depression (Beck depression inventory BDI-II)
Time Frame
4 hours
Title
correlation of EFN scores with socio-clinical characteristics (9)
Description
Evalulation of impulsive behavior (UPSS)
Time Frame
4 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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, ...)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elena MORO, MD PhD
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80 054
Country
France
Facility Name
CHU de Bordeaux-Hôpital Pellegrin
City
Bordeaux
ZIP/Postal Code
33 076
Country
France
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
University hospital grenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Hospices Civils Lyon (HCL)
City
Lyon
ZIP/Postal Code
69 677
Country
France
Facility Name
CHRU Strasbourg
City
Strasbourg
ZIP/Postal Code
67091
Country
France

12. IPD Sharing Statement

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