Reduce pain and autonomic symptoms
- Trial ID
- NCT05748028
- Official Title
- Pain and Autonomic Symptoms in Parkinson's Disease and Atypical Parkinsonisms: Identification of Predictive Patterns of Rehabilitation Outcome and Evaluation of the Impact on Quality of Life
- Goal
- Reduce pain and autonomic symptoms
- Status
- RECRUITING
- Sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Study Type
- OBSERVATIONAL
- Enrollment
- 280 participants
- Conditions
- Parkinson Disease, Multiple System Atrophy
- Interventions
- Rehabilitation, Administration of Clinical scales
Summary For Families
The goal is to find which patterns of pain and autonomic symptoms, like dizziness when standing, constipation, urinary problems, or abnormal sweating, predict who will get the most benefit from rehabilitation and how those symptoms shape quality of life for people with Parkinson's disease or multiple system atrophy. Participants take part in rehabilitation focused on improving mobility, reducing pain, and managing autonomic problems, while researchers use validated clinical scales to measure pain, orthostatic blood pressure changes, bowel and bladder symptoms, mood, and quality of life, then link those measures to rehab outcomes. The study is looking for adults 18 and older with a clinical diagnosis of Parkinson's disease or MSA and a Mini-Mental State Examination score of at least 10, and it excludes people with vascular or drug-induced parkinsonism, diabetes, major liver or kidney disorders, thyroid disease, or use of potentially neurotoxic drugs.
Locations
- ICS Maugeri - IRCCS of Telese Terme, Telese Terme, Benevento, Italy
- ICS Maugeri - Lumezzane, Lumezzane, Brescia, Italy
- ICS Maugeri - Castelgoffredo, Castel Goffredo, Mantova, Italy
- ICS Maugeri - Mistretta, Mistretta, Messina, Italy
- ICS Maugeri - Veruno, Veruno, Novara, Italy
- ICS Maugeri - Montescano, Montescano, Pavia, Italy
- ICS Maugeri - Milano, Milan, Italy
- ICS Maugeri - Pavia Boezio, Pavia, Italy
- ICS Maugeri - Pavia, Pavia, Italy
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Rehabilitation. The goal is to find which patterns of pain and autonomic symptoms, like dizziness when standing, constipation, urinary problems, or abnormal sweating, predict who will get the most benefit from rehabilitation and how those symptoms shape quality of life for people with Parkinson's disease or multiple system atrophy. Participants take part in rehabilitation focused on improving mobility, reducing pain, and managing autonomic problems, while researchers use validated clinical scales to measure pain, orthostatic blood pressure changes, bowel and bladder symptoms, mood, and quality of life, then link those measures to rehab outcomes. The study is looking for adults 18 and older with a clinical diagnosis of Parkinson's disease or MSA and a Mini-Mental State Examination score of at least 10, and it excludes people with vascular or drug-induced parkinsonism, diabetes, major liver or kidney disorders, thyroid disease, or use of potentially neurotoxic drugs.
- Who can participate?
- Participants must be at least 18 Years.
- Where is this trial located?
- This trial is recruiting at 9 locations.
- 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 7 years and 4 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.