Actively Recruiting
Study of the Test-retest Reliability of the Neuropsychiatric Fluctuations Scale in Parkinson's Disease
Led by University Hospital, Grenoble · Updated on 2025-01-20
100
Participants Needed
1
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying neuropsychiatric fluctuations (NPF) in people with Parkinson's disease, which involve changing episodes of symptoms like depression, anxiety, apathy, hypomania, impulsivity, and attention problems. These fluctuations can affect the quality of life for patients and their caregivers and may increase the risk of self-medication and addiction to Parkinson's treatments. To better assess these fluctuations, a 20-item questionnaire called the Neuropsychological Fluctuations Scale (NFS) was developed and shown to be reliable and valid in recent studies. This study focuses on evaluating the test-retest reliability of the NFS to confirm its consistency over time. Participants will complete the self-administered NFS questionnaire during the study. No additional treatments or interventions are involved, and the study aims to finalize the validation of the NFS tool for clinical use. Participants will be asked to complete the NFS questionnaire twice, with a four-week interval between the tests, to measure the stability of the results. Researchers will evaluate the test-retest reliability as the primary outcome. The study includes assessments of motor fluctuations and requires participants to have stable Parkinson's treatment. The total participation period involves these two questionnaire sessions over a month.
CONDITIONS
Official Title
Study of the Test-retest Reliability of the Neuropsychiatric Fluctuations Scale in Parkinson's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 30 and up to 75 years
- Diagnosis of idiopathic Parkinson's disease according to Movement Disorders Society criteria
- Presence of motor fluctuations reported by patient, relatives, or clinician
- Stable antiparkinsonian treatment for at least one month
- Ability to understand and complete questionnaires in French
- Ability to provide informed consent
- Affiliated to the social security system
You will not qualify if you...
- Parkinsonian syndrome other than idiopathic Parkinson's disease
- Dementia with a MoCa score less than 23
- No antiparkinsonian treatment or treatment changed within the last month
- Being a protected person as defined by French regulations (including pregnant or breastfeeding women, persons deprived of liberty, psychiatric care under specific laws, minors, or those unable to consent)
- Currently excluded from another interventional study
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Trial Site Locations
Total: 1 location
1
CHUGA
Grenoble, France
Actively Recruiting
Research Team
E
Emmanuelle Schmitt, PHD
A
Andrea Kistner
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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