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

Grenoble Alpes University Hospital Center (CHU) logo

Grenoble Alpes University Hospital Center (CHU)

Status

Completed

Conditions

Fluctuating Mood Symptoms
Parkinson Disease

Treatments

Other: FN scale auto-questionnaire

Study type

Interventional

Funder types

Other

Identifiers

NCT04455074
2020-A00862-37 (Other Identifier)
38RC20.116

Details and patient eligibility

About

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.

Full 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.

Enrollment

130 patients

Sex

All

Ages

35 to 75 years old

Volunteers

No 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, ...)

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

130 participants in 1 patient group

PD patients with motor fluctuations
Experimental group
Description:
FN scale is an autoquestionnaire consisting of 20 questions, to be answered in On-med and OFF-med condition
Treatment:
Other: FN scale auto-questionnaire

Trial contacts and locations

6

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Central trial contact

Emmanuelle SCHMITT; Elena MORO, MD PhD

Data sourced from clinicaltrials.gov

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