Assessing a new questionnaire for neuropsychiatric fluctuations in Parkinson's disease
Study of the Test-retest Reliability of the Neuropsychiatric Fluctuations Scale (EFN)
This study is testing a new questionnaire to see if it can reliably measure mood and behavior changes in people with Parkinson's disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 30 Years to 75 Years |
| Sex | All |
| Sponsor | University Hospital, Grenoble Academic / other |
| Locations | 1 site (Grenoble) |
| Trial ID | NCT06701955 on ClinicalTrials.gov |
What this trial studies
This study evaluates the Neuropsychological Fluctuations Scale (NFS), a 20-item questionnaire designed to assess neuropsychiatric fluctuations in patients with Parkinson's disease. The research aims to establish the test-retest reliability of the NFS, which has shown promising psychometric properties in previous studies. Participants will complete the questionnaire and undergo a physical exam to ensure comprehensive evaluation. This validation step is crucial for confirming the NFS as a reliable tool for assessing non-motor symptoms in Parkinson's disease.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 30 to 75 with idiopathic Parkinson's disease experiencing motor fluctuations.
Not a fit: Patients with Parkinsonian syndromes other than idiopathic Parkinson's disease or those with significant cognitive impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a validated tool for better assessing and managing neuropsychiatric symptoms in Parkinson's disease, ultimately improving patient care.
How similar studies have performed: Previous studies have shown promising results with similar assessment tools, indicating potential for success in this validation effort.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Grenoble
- Chuga — Grenoble, France (Recruiting)
Study contacts
- Study coordinator: Emmanuelle Schmitt, PHD
- Email: eschmitt@chu-grenoble.fr
- Phone: +33 4 76765791
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.