Status:
UNKNOWN
Simultaneous DBS of the GPi and the NBM in Patients With Parkinson's Disease and Mild Cognitive Impairment
Lead Sponsor:
University of Sao Paulo General Hospital
Conditions:
Parkinson Disease
Mild Cognitive Impairment
Eligibility:
All Genders
50-75 years
Phase:
NA
Brief Summary
Phase 1 study evaluating the safety of combined bilateral globus pallidus internus (GPi) and nucleus basalis of Meynert (NBM) stimulation in treating levodopa responsive motor symptoms of Parkinsonism...
Detailed Description
This study aims to provide a proof of safety of combined bilateral Globus Pallidus internus (GPi) and Nucleus Basalis of Meynert (NBM) stimulation in patients with moderate to advanced Parkinson's dis...
Eligibility Criteria
Inclusion
- Age at the time of enrollment: 50 - 75 years.
- Diagnosis of idiopathic PD according to Movement Disorders Society (MDS) criteria (Albanese et al., 2017).
- Mild cognitive impairment (MCI) related to Parkinson's disease according to MDS criteria. (Livtan et al. 2012).
- Duration of bilateral idiopathic PD: ≥ 5 years of motor symptoms.
- Modified Hoehn and Yahr stage ≥ 2 on off medication state.
- UPDRS subset III (motor) ≥ 30 points on off medication state.
- Levodopa must improve PD symptoms by ≥ 30% in a levodopa challenge test, as measured by UPDRS subset III score.
- Presence of motor complications related to Parkinson's disease.
- Be willing and able to comply with all visits and study related procedures
- Able to understand the study requirements and the treatment procedures and to provide written informed consent before any study-specific tests or procedures are performed.
Exclusion
- Alcohol or drug abuse.
- Any significant psychiatric problems, including acute confusional state (delirium), ongoing psychosis, or clinically significant depression.
- Contraindications for deep brain stimulation (DBS) surgery.
- Heart failure, heart disease or any condition that contraindicates surgical procedures.
- Pacemaker or other active implanted stimulators.
- Clearly established Parkinson's disease dementia according to Movement Disorders Criteria.
- Participation in another drug, device, or biologics trial concurrently.
Key Trial Info
Start Date :
July 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05320523
Start Date
July 20 2021
End Date
January 1 2024
Last Update
April 11 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of São Paulo General Hospital
São Paulo, Brazil, 05403000