Parkinson's Trial NCT07316751
Assess Parkinson symptoms in Italian
- Trial ID
- NCT07316751
- Official Title
- Italian Translation and Validation of the GIDS-PD Scale for Parkinson's Disease
- Goal
- Assess Parkinson symptoms in Italian
- Status
- RECRUITING
- Sponsor
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
- Study Type
- OBSERVATIONAL
- Enrollment
- 190 participants
- Conditions
- PARKINSON DISEASE (Disorder), Parkinson Disease
Summary For Families
The goal is to produce and validate an Italian version of the GIDS-PD scale so clinicians and researchers have a reliable tool to measure Parkinson's symptom severity and how those symptoms affect daily life in Italian-speaking patients. The team will translate the questionnaire and then test it in about 190 people, checking that the questions are clear, consistent, and accurately reflect patients' symptoms and function; no drug or device is given because it is an observational validation. Adults 18 and older with Parkinson's diagnosed by the MDS criteria who understand Italian and can give consent are eligible, while people in the terminal phase, with significant cognitive impairment, or with non-PD parkinsonism are excluded.
Locations
- Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy
- Ospedale Universitario Luigi Sacco, Milano, Italia, Milan, Italy
- Unità Parkinson e Disturbi del Movimento, Dipartimento di Neuroscienze(DNS), Università di Padova, Padova, Italia, Padova, Italy
- Centro per le Malattie Neurodegenerative e l'Invecchiamento Cerebrale, Università degli Studi di Bari "Aldo Moro" presso la Pia Fondazione "Card. G. Panico", Tricase, Italia, Tricase, Italy
- Unità di Neurologia, Divisione Malattia di Parkinson e Disturbi del Movimento, Dipartimento di Neuroscienze, Biomedicina e Scienze del Movimento, Università di Verona, Italia, Verona, Italy
Frequently Asked Questions
- What is this trial testing?
- This trial is studying an experimental treatment. The goal is to produce and validate an Italian version of the GIDS-PD scale so clinicians and researchers have a reliable tool to measure Parkinson's symptom severity and how those symptoms affect daily life in Italian-speaking patients. The team will translate the questionnaire and then test it in about 190 people, checking that the questions are clear, consistent, and accurately reflect patients' symptoms and function; no drug or device is given because it is an observational validation. Adults 18 and older with Parkinson's diagnosed by the MDS criteria who understand Italian and can give consent are eligible, while people in the terminal phase, with significant cognitive impairment, or with non-PD parkinsonism are excluded.
- Who can participate?
- Participants must be at least 18 Years.
- Where is this trial located?
- This trial is recruiting at 5 locations.
- Does it cost anything to join?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 3 years and 1 month.
- 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.
- 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.
- Will I get a placebo in this trial?
- This is an observational study, so there is no placebo and no experimental treatment is assigned. Researchers observe and collect information while you continue your usual care.