Translation and validation of a questionnaire for non-motor symptoms in Parkinson's disease
Italian Translation and Validation of the Non-Motor Fluctuation Assessment (NoMoFA) Questionnaire.
This study is testing a new Italian version of a questionnaire to help understand the non-motor symptoms in people with Parkinson's disease and how these symptoms affect their quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Sex | All |
| Sponsor | A.O.U. Città della Salute e della Scienza Academic / other |
| Locations | 1 site (Torino, TO) |
| Trial ID | NCT06406374 on ClinicalTrials.gov |
What this trial studies
This observational study aims to translate and validate the Non-Motor Fluctuation Assessment (NoMoFA) questionnaire for Italian-speaking patients with Parkinson's disease. It will involve 200 consecutive patients who will provide demographic and clinical data, undergo clinical examinations, and complete the NoMoFA questionnaire during regular follow-up visits. The study will also assess the reliability of the Italian version of the NoMoFA through a test-retest method with a subset of patients. The goal is to better understand non-motor fluctuations in Parkinson's disease and their impact on patient quality of life.
Who should consider this trial
Good fit: Ideal candidates are Italian-speaking patients diagnosed with idiopathic Parkinson's disease who experience symptom fluctuations.
Not a fit: Patients with atypical Parkinsonian syndromes or those with advanced disease (Hoehn and Yahr stage >4) may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the assessment of non-motor symptoms in Parkinson's disease, leading to improved patient management and quality of life.
How similar studies have performed: While the approach of validating a questionnaire for non-motor symptoms is common, the specific focus on the Italian version of the NoMoFA is a novel effort.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of idiopathic Parkinson\'s disease according to the 2015 Movement Disorders Society (MDS) criteria (Postuma et al. Mov Dis, 2015); * Italian speaker; * Mini-mental state examinations (MMSE) score \>25; * Presence of symptoms fluctuations, as per a Wearing-off questionnaire 19 (WOQ-19) score\>=2; * Stable antiparkinsonian medications for at least three months * Ability to provide informed consent. Exclusion Criteria: * Atypical Parkinsonian syndrome * H\&Y\>4 * Patients under legal protection
Where this trial is running
Torino, TO
- Dipartimento di Neuroscienze e Salute Mentale SC Neurologia 2U — Torino, To, Italy (Recruiting)
Study contacts
- Study coordinator: Carlo Alberto Artusi, MD, PhD
- Email: carloalberto.artusi@unito.it
- Phone: +390116709366
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.