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NCT Number: NCT06701955

Study of the Test-retest Reliability of the Neuropsychiatric Fluctuations Scale in Parkinson's Disease

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.

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Key information

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHUGA

Grenoble, France

Location status: Recruiting

Location contact

Andréa KISTNER

CONTACT

Emmanuelle SCHMITT

CONTACT

Emmanuelle SCHMITT

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age > 30 and ≤ 75 years

  • Idiopathic Parkinson's disease (according to the criteria of the Movement Disorders Society)
  • Presence of motor fluctuations described by the patient, their relatives, or identified by the clinician
  • Stability of antiparkinsonian treatment for at least one month
  • Mastery of the French language
  • Able to give consent.
  • Affiliated to the social security system

Exclusion criteria

Parkinsonian syndrome other than idiopathic Parkinson's disease

  • Dementia (MoCa < 23)
  • No antiparkinsonian treatment or treatment modified for less than one month
  • Persons referred to in Articles L1121-5 to L1121-8 of the CSP (corresponds to all protected persons: pregnant women, parturients, breastfeeding mothers, persons deprived of liberty by judicial or administrative decision, persons receiving psychiatric care under Articles L. 3212-1 and L. 3213-1 who are not covered by the provisions of Article L. 1121-8, persons admitted to a health or social establishment for purposes other than research, minors, persons subject to a legal protection measure or unable to express their consent))
  • Subject in a period of exclusion from another interventional study.

Treatment and study plan

Questionnaire and Physical Exam

Other

self administered questionnaires

Primary outcomes

  1. validation of test-retest reliabililty

    Time frame: 4 weeks

    validation of test-retest reliabililty of the neuropsychiatric fluctuations scale

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea Kistner

CONTACT

[email protected]

Emmanuelle Schmitt, PHD

CONTACT

[email protected]

+33 4 76765791

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

Study of the Test-retest Reliability of the Neuropsychiatric Fluctuations Scale (EFN)

Acronym: EFN-RETEST

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Nov 22, 2024
Registry last updated
Jan 20, 2025

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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