Fluctuating Mood Symptoms, Parkinson Disease
Conditions
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.
Interventions
OTHERFN 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.
Sponsors
University Hospital, Clermont-Ferrand
University Hospital, Grenoble
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
No
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, ...)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| validation of FN scale: acceptability | 4 hours | EFN score |
| validation of FN scale: realiability | 2 months | EFN score |
| validation of FN scale: internal consistency | 4 hours | EFN score |
| validation of FN scale: measurement error | 2 months | test-retest |
| validation of FN scale: structural validity | 4 hours | EFN score |
| validation of FN scale: responsiveness | 4 hours | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| correlation of EFN scores with socio-clinical characteristics 2 | 4 hours | Severity of PD (Clinical Impression of Severity Index for PD - CISI-PD) |
| correlation of EFN scores with socio-clinical characteristics 3 | 4 hours | stage of PD (Hoehn & Yahr stage) |
| correlation of EFN scores with socio-clinical characteristics (4) | 4 hours | cognitif state (Montreal cognitive assessment - MoCA test) |
| correlation of EFN scores with socio-clinical characteristics (9) | 4 hours | Evalulation of impulsive behavior (UPSS) |
| correlation of EFN scores with socio-clinical characteristics (8) | 4 hours | Depression (Beck depression inventory BDI-II) |
| correlation of EFN scores with socio-clinical characteristics (5) | 4 hours | Impulsive-Compulsive Disorders (QUIP-RS) |
| correlation of EFN scores with socio-clinical characteristics (6) | 4 hours | Dopamine-dependant behavior (ACDD) |
| correlation of EFN scores with socio-clinical characteristics (7) | 4 hours | Wearing off (QUICK questionnaire) |
| correlation of EFN scores with socio-clinical characteristics 1 | 4 hours | MDS-UPDRS |
Countries
France
Outcome results
None listed