Evaluating outcomes of frameless deep brain stimulation in Parkinson's disease
Short- and Long-term Behavioral, Cognitive and Motor Outcomes of Frameless Deep Brain Stimulation in Patients With Parkinson's Disease: a Prospective Observational Study
This study is testing how frameless deep brain stimulation surgery affects the quality of life for people with Parkinson's disease over the short and long term.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Rome) |
| Trial ID | NCT05752656 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the short- and long-term effects of frameless deep brain stimulation surgery on patients with Parkinson's disease. It will measure improvements in quality of life using the PDQ-39 scale by comparing scores before surgery and one year post-surgery. The study will involve clinical examinations to gather data on behavioral, cognitive, and motor outcomes associated with the intervention.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with idiopathic Parkinson's disease who are eligible for deep brain stimulation surgery.
Not a fit: Patients who are unable to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly enhance the quality of life for patients with Parkinson's disease through improved treatment outcomes.
How similar studies have performed: Other studies have shown promising results with deep brain stimulation techniques, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * diagnosis of idiopathic Parkinson's disease according to Movement Disorder Society (MDS) criteria; * patients who are candidates for deep brain stimulation intervention, according to the international criteria of the "Core assessment program for surgical interventional therapies in Parkinson's disease" (CAPSIT-PD). Exclusion Criteria: \- patients unable to give informed consent.
Where this trial is running
Rome
- Flavia Torlizzi — Rome, Italy (Recruiting)
Study contacts
- Study coordinator: Francesco Bove, MD
- Email: francesco.bove@policlinicogemelli.it
- Phone: +390630156433
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.