Circuit-Based Deep Brain Stimulation for Parkinson's Disease P1A2&3 Catalyst
Overview
- Phase
- Not Applicable
- Intervention
- Parkinson's disease
- Conditions
- Parkinson Disease
- Sponsor
- University of Minnesota
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- N-back task trials
- Status
- Recruiting
- Last Updated
- 3 months ago
Overview
Brief Summary
This study will help us better understand how the brain works in people with Parkinson's disease (PD). PD is a brain disease that gets worse over time, and affects over 10 million people world-wide. A common treatment for PD is Deep Brain Stimulation (DBS). To improve DBS therapy for PD, we need a deeper understanding of how the different parts of the brain work together in PD, and how this relates to movement and thinking problems that people with PD experience.
We may be able to use the results of this study to improve DBS treatments in the future.
Detailed Description
Parkinson's disease (PD) is a progressive neurodegenerative disease affecting over 10 million people world-wide. It can be a debilitating disorder and although studied for decades, the physiological changes in the basal ganglia thalamocortical (BGTC) circuit that underlie its development remain under debate. Deep brain stimulation (DBS) of the subthalamic nucleus (STN) and internal globus pallidus (GPi) has been a highly effective therapy for many patients with PD, however, the results have been highly variable and may be associated with cognitive compromise in some patients. To advance DBS therapies for PD we require a deeper understanding of the local and network-wide circuit dynamics and their relationship to motor signs and cognitive function. This understanding will provide the rationale for optimizing STN and GPi DBS, targeting specific regions within the STN and GPi, and development of patient-specific DBS based on the patients' motor signs and cognitive profile
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of idiopathic PD
- •Surgery at UMN to implant DBS system with directional lead(s) and multiple independent current control IPG is planned as part of routine clinical care
- •At least 21 years old
Exclusion Criteria
- •Other significant neurological disorder
- •History of dementia
- •Patients with post-operative complications or adverse effects (e.g. ON stimulation dystonias) that affect patient safety or confound the experiment will be excluded from further study
- •Pregnant women
- •Known radiation exposure within the last year that is determined to be unsafe when compounded with the expected radiation dose from intraoperative fluoroscopy to place ECoG strip
Arms & Interventions
Parkinson's disease
* Diagnosis of idiopathic PD * Surgery at UMN to implant DBS system with directional lead(s) and multiple independent current control IPG is planned as part of routine clinical care * At least 21 years old * Existing or planned 7T brain imagery
Outcomes
Primary Outcomes
N-back task trials
Time Frame: 2 days
directed connectivity between STN and DLPFC compared between the N-back task trials with and without stimulation.
reach-related modulation
Time Frame: 2 days
reach-related modulation in beta/HFO power in DBS lead LFPs across OFF, DBS, L-dopa, and DBS+L-dopa conditions.
peak frequency of the ERs + spontaneous LFPs
Time Frame: 1 day
the correlation between the peak frequency of the ERs in the GPi (or STN) and that of spontaneous LFPs in the GPi (or STN).
rigidity and bradykinesia assessments
Time Frame: 1 day
differences in rigidity and bradykinesia assessments between conditions: off-stimulation vs eiDBS-suppression, off-stimulation vs eiDBS-amplification, eiDBS-suppression vs eiDBS-amplification.
Secondary Outcomes
- N-back task trials(2 days)
- rigidity/bradykinesia measurements and correlations to conditions(1 day)
- task vs. rest and topographical location(2 days)