Understanding pain and autonomic symptoms in Parkinson's disease and atypical parkinsonisms
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
This study looks at how pain and other symptoms affect people with Parkinson's disease and multiple system atrophy to see if rehabilitation can help improve their quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 280 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Istituti Clinici Scientifici Maugeri SpA Academic / other |
| Locations | 9 sites (Telese Terme, Benevento and 8 other locations) |
| Trial ID | NCT05748028 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the prevalence and characteristics of pain and autonomic symptoms in patients diagnosed with Parkinson's disease (PD) and multiple system atrophy (MSA). It will evaluate the effects of rehabilitation on these symptoms and assess their impact on the quality of life of the participants. Patients will undergo neurological examinations, participate in rehabilitation programs, and complete clinical scales to gather comprehensive data. The study will compare the experiences of patients with PD and MSA to better understand their unique challenges and treatment responses.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with Parkinson's disease or multiple system atrophy who meet specific clinical criteria.
Not a fit: Patients with vascular or pharmacological parkinsonism, diabetes mellitus, or those on potentially neurotoxic drugs may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for pain and autonomic symptoms in patients with Parkinson's disease and MSA, enhancing their quality of life.
How similar studies have performed: While there is growing interest in the non-motor symptoms of Parkinson's disease, this specific approach to evaluating pain and autonomic symptoms in relation to rehabilitation is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Clinical diagnosis of Parkinson's Disease or Multiple System Atrophy according to current international criteria (Gilman S et al, 2008; Postuma RB et al. 2015). * Mini-Mental State Examination score at least 10 Exclusion Criteria: * vascular or pharmacological parkinsonism * diabetes mellitus * hepatic or renal dysmetabolism, * hypothyroidism or hyperthyroidism * assumption of potentially neurotoxic drugs
Where this trial is running
Telese Terme, Benevento and 8 other locations
- ICS Maugeri - IRCCS of Telese Terme — Telese Terme, Benevento, Italy (Recruiting)
- ICS Maugeri - Lumezzane — Lumezzane, Brescia, Italy (Recruiting)
- ICS Maugeri - Castelgoffredo — Castel Goffredo, Mantova, Italy (Recruiting)
- ICS Maugeri - Mistretta — Mistretta, Messina, Italy (Recruiting)
- ICS Maugeri - Veruno — Veruno, Novara, Italy (Recruiting)
- ICS Maugeri - Montescano — Montescano, Pavia, Italy (Recruiting)
- ICS Maugeri - Milano — Milan, Italy (Recruiting)
- ICS Maugeri - Pavia Boezio — Pavia, Italy (Recruiting)
- ICS Maugeri - Pavia — Pavia, Italy (Recruiting)
Study contacts
- Principal investigator: Maria Nolano, MD, PhD — Isituti Clinici Scientifici Maugeri SpA SB - IRCCS of Telese Terme
- Study coordinator: Maria Nolano, MD, PhD
- Email: maria.nolano@icsmaugeri.it
- Phone: +390824909257
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.