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

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ClinicalTrials.gov Identifier: NCT04455074
Recruitment Status : Recruiting
First Posted : July 2, 2020
Last Update Posted : January 9, 2023
Sponsor:
Collaborator:
University Hospital, Clermont-Ferrand
Information provided by (Responsible Party):
University Hospital, Grenoble

Study Description
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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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Fluctuating Mood Symptoms Other: FN scale auto-questionnaire Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: French Validation Study of a New Scale for Neuropsychiatric Fluctuations in Parkinson Disease
Actual Study Start Date : September 23, 2020
Estimated Primary Completion Date : March 23, 2023
Estimated Study Completion Date : March 23, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: PD patients with motor fluctuations
FN scale is an autoquestionnaire consisting of 20 questions, to be answered in On-med and OFF-med condition
 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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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)


Eligibility Criteria
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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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, ...)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04455074


Contacts
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Contact: Elena MORO, MD PhD 33 (0)4 7676 5791 emoro@chu-grenoble.fr
Contact: Emmanuelle SCHMITT eschmitt@chu-grenoble.fr

Locations
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France
CHU Amiens Recruiting
Amiens, France, 80 054
Contact: Stéphanie BLIN    33 (0)3 22 66 80 00 ext 63 206    Blin.Stephanie@chu-amiens.fr   
Principal Investigator: Mélissa TIR         
CHU de Bordeaux-Hôpital Pellegrin Not yet recruiting
Bordeaux, France, 33 076
Contact: Sandrine DUPOUY    33 (0)5.57.82.14.62 ext 21462    sandrine.dupouy@chu-bordeaux.fr   
Principal Investigator: WASSILIOS MEISSNER         
CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Isabelle RIEU    33 (0)4 73 75 49 91    irieu@chu-clermontferrand.fr   
Principal Investigator: Franck DURIF         
University hospital grenoble Recruiting
Grenoble, France, 38043
Hospices Civils Lyon (HCL) Recruiting
Lyon, France, 69 677
Contact: Catherine CAIRE    33 (0)4 27855188    catherine.caire@chu-lyon.fr   
Principal Investigator: Stéphane THOBOIS         
CHRU Strasbourg Recruiting
Strasbourg, France, 67091
Contact: Fanny HUSELSTEIN    33 (0)3.88.12.86.42    fanny.huselstein@chru-strasbourg.fr   
Principal Investigator: Mathieu ANHEIM         
Sponsors and Collaborators
University Hospital, Grenoble
University Hospital, Clermont-Ferrand
Investigators
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Principal Investigator: Elena MORO, MD PhD University Hospital, Grenoble
More Information
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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT04455074    
Other Study ID Numbers: 38RC20.116
2020-A00862-37 ( Other Identifier: ID RCB )
First Posted: July 2, 2020    Key Record Dates
Last Update Posted: January 9, 2023
Last Verified: January 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases