Evaluating long-term effects of deep brain stimulation on behavior and cognition in Parkinson's disease
Long-Term Behavioral and Cognitive Outcomes of Deep Brain Stimulation in Patients With Parkinson's Disease
This study is testing how deep brain stimulation affects thinking and behavior over time in people with Parkinson's disease compared to those just taking medication.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 52 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico Academic / other |
| Locations | 1 site (Milan, Lombardy) |
| Trial ID | NCT06329726 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the long-term behavioral and cognitive outcomes of deep brain stimulation (DBS) in patients with Parkinson's disease. Participants will undergo initial assessments and annual follow-ups over a five-year period, utilizing tests, questionnaires, and standardized clinical scales. The study will compare outcomes between patients receiving DBS and those on the best medical therapy to determine the effectiveness of DBS in improving cognitive and behavioral functions.
Who should consider this trial
Good fit: Ideal candidates include Parkinson's disease patients who are candidates for deep brain stimulation or those receiving the best medical treatment.
Not a fit: Patients unable to complete study assessments may not receive any benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the long-term benefits of deep brain stimulation for improving cognitive and behavioral outcomes in Parkinson's disease patients.
How similar studies have performed: Other studies have shown promising results regarding the cognitive and behavioral impacts of deep brain stimulation in Parkinson's disease, suggesting this approach is supported by prior research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Parkinson's disease patients candidates for DBS of the subthalamic nucleus * Parkinson's disease patients with best medical treatment Exclusion Criteria: * patients unable to complete study assessments
Where this trial is running
Milan, Lombardy
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico — Milan, Lombardy, Italy (Recruiting)
Study contacts
- Principal investigator: Francesca Mameli, Dr — Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Study coordinator: Fabiana Ruggiero, Dr
- Email: fabiana.ruggiero@policlinico.mi.it
- Phone: 0255033621
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.