CHUGA
Grenoble, France
Location status: Recruiting
Location contact
Andréa KISTNER
CONTACT
Emmanuelle SCHMITT
CONTACT
Emmanuelle SCHMITT
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06701955
This study focuses on neuropsychiatric fluctuations (NPF) in Parkinson's disease. Due to the lack of specific assessment tools, we developed the Neuropsychological Fluctuations Scale (NFS), a 20-item questionnaire. Recent studies have confirmed its reliability, sensitivity, and validity. To finalize its validation, assessing its test-retest reliability is an essential next step.
Interested in participating?
Request Info30 year–75 year
All sexes
Interventional
Not applicable
Grenoble, France
Location status: Recruiting
Andréa KISTNER
CONTACT
Emmanuelle SCHMITT
CONTACT
Emmanuelle SCHMITT
PRINCIPAL_INVESTIGATOR
During the progression of Parkinson's disease, a large number of patients experience fluctuations in motor status associated with neuropsychiatric fluctuations (NPF) (alternating episodes of depression, anxiety, and apathy with hypomanic states, impulsivity, and attention disorders). NPF may have a significant impact on patients' quality of life as well as on that of their caregivers. Moreover, the presence of these fluctuations is a risk factor for the development of self-medication behaviors, which can lead to addiction to antiparkinsonian treatments.
Due to the lack of specific tools for assessing NPF, our team developed a 20-item self-questionnaire specifically evaluating NPF in acute phases: the Neuropsychological Fluctuations Scale (NFS), which was first published in Movement Disorders, Clinical Practice (Schmitt et al., 2018). Recently, we studied the psychometric properties of the NFS in two populations of Parkinson's disease patients and in the general population (EFN Pre-Validation and EFN-Validation studies: ClinicalTrials.gov NCT04455074). The results regarding internal consistency, sensitivity, and specificity of the NFS, as well as its internal structure and external validity, were published in Frontiers in Neurology in 2023 (Schmitt et al., 2023). It has been demonstrated that the NFS is an innovative tool that complements existing motor and non-motor evaluations, and its utility in diagnosing and managing NPF is significant.
In order to finalize the validation of the NFS and further understand its psychometric characteristics, assessing the temporal stability of the NFS through test-retest reliability is an essential step.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Age > 30 and ≤ 75 years
Exclusion criteria
Parkinsonian syndrome other than idiopathic Parkinson's disease
self administered questionnaires
Time frame: 4 weeks
validation of test-retest reliabililty of the neuropsychiatric fluctuations scale
Contact information is provided by the study sponsor or research team.
Andrea Kistner
CONTACT
Emmanuelle Schmitt, PHD
CONTACT
University Hospital, Grenoble
Other
Study of the Test-retest Reliability of the Neuropsychiatric Fluctuations Scale (EFN)
Acronym: EFN-RETEST
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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