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
Summary For Families
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.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.