Recruiting · registry status

Checking a questionnaire about changing mood and thinking symptoms

Researchers are testing whether a questionnaire gives consistent results when used repeatedly to measure changes in mental and emotional symptoms in Parkinson’s.

Testing a treatment or activity · Study reference: NCT06701955

Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓

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Who can join?

Ages 30 years to 75 years · Does not accept healthy volunteers

These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.

Read all the rules for taking part

Sex eligibility reported by registry: all

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.

Full study name & original research details

Official study title

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

Short title used by the registry

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

Original description

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.

Further description from the registry

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.

Conditions reported: Parkinson's Disease

Study type: Interventional
Interventions: Questionnaire and Physical Exam
Phases: NA
Sponsor: University Hospital, Grenoble
Start date reported by registry: 2025-01-30 (actual)

Registry updated: 2026-09-30 · Status last verified by the registry submitter: 2026-09

Registry records retrieved 2026-10-11 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.

Contact the research team

Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.

Emmanuelle Schmitt, PHD · +33 4 76765791 · eschmitt@chu-grenoble.fr

Andrea Kistner · akistner@chu-grenoble.fr

Study locations

Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.

CHUGA

Grenoble, France

Recruiting

Emmanuelle SCHMITT

Andréa KISTNER

Emmanuelle SCHMITT

The original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.