Validate Italian non motor fluctuations
- Trial ID
- NCT06406374
- Official Title
- Italian Translation and Validation of the Non-Motor Fluctuation Assessment (NoMoFA) Questionnaire.
- Goal
- Validate Italian non motor fluctuations
- Status
- RECRUITING
- Sponsor
- A.O.U. Città della Salute e della Scienza
- Study Type
- OBSERVATIONAL
- Enrollment
- 200 participants
- Conditions
- Parkinson's Disease
Plain-Language Summary
The goal is to create and check an Italian version of the NoMoFA questionnaire so clinicians can reliably track non-motor fluctuations in Parkinson's, like changes in mood, thinking, sleep, and autonomic symptoms that come and go with medication cycles. The approach is observational, translating and validating the questionnaire by having eligible patients complete it alongside standard measures to confirm it actually detects these on/off non-motor problems and is easy to use in clinic. They are looking for Italian-speaking people diagnosed with idiopathic Parkinson's by MDS criteria who have MMSE scores above 25, report symptom fluctuations on the WOQ-19 (score ≥2), have had stable Parkinson medications for at least three months, and do not have atypical parkinsonism or very advanced disease (Hoehn and Yahr >4). No drug or device is being tested; about 200 participants will be enrolled.
Locations
- Dipartimento di Neuroscienze e Salute Mentale SC Neurologia 2U, Torino, TO, Italy
Frequently Asked Questions
- What is this trial testing?
- This trial is studying an experimental treatment. The goal is to create and check an Italian version of the NoMoFA questionnaire so clinicians can reliably track non-motor fluctuations in Parkinson's, like changes in mood, thinking, sleep, and autonomic symptoms that come and go with medication cycles. The approach is observational, translating and validating the questionnaire by having eligible patients complete it alongside standard measures to confirm it actually detects these on/off non-motor problems and is easy to use in clinic. They are looking for Italian-speaking people diagnosed with idiopathic Parkinson's by MDS criteria who have MMSE scores above 25, report symptom fluctuations on the WOQ-19 (score ≥2), have had stable Parkinson medications for at least three months, and do not have atypical parkinsonism or very advanced disease (Hoehn and Yahr >4). No drug or device is being tested; about 200 participants will be enrolled.
- Who can participate?
- Eligibility criteria vary. Check the full listing on ClinicalTrials.gov for detailed inclusion and exclusion criteria.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 1 year and 2 months.