Profiling Parkinson's Disease and the Effects of Non-Drug Therapies
Clinical, Molecular and Electrophysiological Profiling of Parkinson's Disease: the Role of Non-pharmacological Therapies
This study is testing if motor exercise and brain stimulation can help reduce inflammation and slow down the progression of Parkinson's disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 30 Years to 80 Years |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma) |
| Trial ID | NCT05807581 on ClinicalTrials.gov |
What this trial studies
This project aims to explore the relationship between inflammation and the progression of Parkinson's disease (PD) by investigating the role of alpha-synuclein aggregates. The study will assess the effects of two non-pharmacological therapies, motor exercise and neuromodulation, on neuroinflammation and brain-derived neurotrophic factor (BDNF) production. Clinical assessments will be paired with biomarker measurements from cerebrospinal fluid and blood to understand the underlying mechanisms of disease progression. The hypothesis is that these interventions may help reduce neuroinflammation and the spread of alpha-synuclein.
Who should consider this trial
Good fit: Ideal candidates are individuals with a clinically established diagnosis of Parkinson's disease at Hoehn & Yahr stages 1 to 3.
Not a fit: Patients who are pregnant or have oncological or autoimmune comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved non-pharmacological treatment options for patients with Parkinson's disease.
How similar studies have performed: While the specific approach of combining motor exercise and neuromodulation in this context is novel, similar studies have shown promise in exploring non-pharmacological therapies for Parkinson's disease.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * clinically established diagnosis of PD according to the Movement Disorders Society (MDS) diagnostic criteria * Hoehn \& Yahr (H\&Y) stage between 1 and 3 Exclusion Criteria: * Pregnancy * Oncological or autoimmune comorbidities
Where this trial is running
Roma
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Roma, Italy (Recruiting)
Study contacts
- Study coordinator: Flavia Torlizzi
- Email: flavia.torlizzi@policlinicogemelli.it
- Phone: 0630155633
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.