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
17 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. These fluctuations include changes in mood such as depression, anxiety, apathy, hypomanic states, impulsivity, and attention disorders, which can significantly affect patients' and caregivers' quality of life. The study aims to validate a new tool called the Neuropsychological Fluctuations Scale (NFS), a 20-item questionnaire developed to assess these fluctuations accurately. This research focuses on confirming the test-retest reliability of the NFS, which is important for its final validation. Participants will complete self-administered questionnaires at different time points as part of the study. The main activity involves answering the NFS questionnaire twice, four weeks apart, to assess the consistency of responses over time. The study is randomized but does not involve any drug or placebo treatments, and no blinding is used. The intervention is limited to questionnaires and a physical exam. During the study, participants will be monitored for their responses on the NFS to evaluate its reliability over a four-week period. Researchers will also collect information about participants' Parkinson's symptoms and treatment stability. The total duration includes the initial assessment and a follow-up after four weeks to measure the test-retest reliability. Safety and other health aspects will be observed, with participation lasting as long as the study period requires.
CONDITIONS
Brief 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 75 years or younger
- Diagnosed with idiopathic Parkinson's disease according to Movement Disorders Society criteria
- Experience motor fluctuations described by self, relatives, or clinician
- Stable antiparkinsonian treatment for at least one month
- Able to read and understand French
- Able to give consent
- Affiliated with the social security system
You will not qualify if you...
- Parkinsonian syndrome other than idiopathic Parkinson's disease
- Dementia with MoCa score less than 23
- No antiparkinsonian treatment or treatment changed within the last month
- Protected persons such as pregnant or breastfeeding women, persons deprived of liberty, or under psychiatric care without consent
- Persons admitted to health or social establishments for non-research reasons
- Minors or persons unable to consent
- Currently excluded from other interventional studies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants complete self-administered questionnaires at different time points to assess the test-retest reliability of the Neuropsychiatric Fluctuations Scale.
2 visits (in-person) spaced 4 weeks apart
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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