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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A00862-37 | Other Identifier | ID RCB |
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| Name | Class |
|---|---|
| University Hospital, Clermont-Ferrand | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PD patients with motor fluctuations | Experimental | FN scale is an autoquestionnaire consisting of 20 questions, to be answered in On-med and OFF-med condition |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FN scale auto-questionnaire | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| validation of FN scale: realiability | EFN score | 2 months |
| validation of FN scale: internal consistency | EFN score | 4 hours |
| validation of FN scale: measurement error | test-retest | 2 months |
| validation of FN scale: structural validity | EFN score | 4 hours |
| validation of FN scale: responsiveness | 4 hours | |
| validation of FN scale: acceptability | EFN score | 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| correlation of EFN scores with socio-clinical characteristics 1 | MDS-UPDRS | 4 hours |
| correlation of EFN scores with socio-clinical characteristics 2 | Severity of PD (Clinical Impression of Severity Index for PD - CISI-PD) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elena MORO, MD PhD | University Hospital, Grenoble | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Amiens | Amiens | 80 054 | France | |||
| CHU de Bordeaux-Hôpital Pellegrin |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40683099 | Result | Schmitt E, Bouvard M, Anheim M, Guehl D, Klinger H, Laurencin C, Marques A, Meissner WG, Thobois S, Thomas J, Tir M, Debu B, Moro E; NFS-VALID Study. Neuropsychiatric fluctuations in Parkinson's disease: A French multicenter study of the NFS psychometric properties. Parkinsonism Relat Disord. 2025 Sep;138:107954. doi: 10.1016/j.parkreldis.2025.107954. Epub 2025 Jul 11. |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| 4 hours |
| correlation of EFN scores with socio-clinical characteristics 3 | stage of PD (Hoehn & Yahr stage) | 4 hours |
| correlation of EFN scores with socio-clinical characteristics (4) | cognitif state (Montreal cognitive assessment - MoCA test) | 4 hours |
| correlation of EFN scores with socio-clinical characteristics (5) | Impulsive-Compulsive Disorders (QUIP-RS) | 4 hours |
| correlation of EFN scores with socio-clinical characteristics (6) | Dopamine-dependant behavior (ACDD) | 4 hours |
| correlation of EFN scores with socio-clinical characteristics (7) | Wearing off (QUICK questionnaire) | 4 hours |
| correlation of EFN scores with socio-clinical characteristics (8) | Depression (Beck depression inventory BDI-II) | 4 hours |
| correlation of EFN scores with socio-clinical characteristics (9) | Evalulation of impulsive behavior (UPSS) | 4 hours |
| Bordeaux |
| 33 076 |
| France |
| CHU Clermont-Ferrand | Clermont-Ferrand | 63003 | France |
| University hospital grenoble | Grenoble | 38043 | France |
| Hospices Civils Lyon (HCL) | Lyon | 69 677 | France |
| CHRU Strasbourg | Strasbourg | 67091 | France |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |