Advancing Pre-operative Targeting for Deep Brain Stimulation in the Globus Pallidus Internus: Functional Segmentation Based on Probabilistic Tractography
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Mayo Clinic
- Enrollment
- 1
- Locations
- 3
- Primary Endpoint
- Change in Unified Parkinson's Disease Rating Scale III (UPDRS-III)
Study Overview
Brief Summary
In the proposed pilot project, MRI data will be prospectively collected to show the feasibility of the segmentation algorithm and the potential relation to final lead positioning. Patients will be selected from those undergoing GPi DBS placement. This pilot data will serve as a basis for pursuing funding for a larger trial evaluating the prospective ability of the 3T targeting study to improve outcomes and decrease complications in GPi DBS placement. Improved outcomes and patient experience would be expected to further contribute to our facility as a center of excellence for treatment of movement disorders.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient with the diagnosis of Parkinson's Disease selected for placement of globus pallidus internus (GPi) deep brain stimulator (DBS)
Exclusion Criteria
- Not provided
Arms & Interventions
GPi DBS
Patients selected to undergo GPi DBS placement will be eligible for enrollment in the study. In addition to standard-of-care tests, subjects will undergo an MRI consisting of the proposed novel imaging protocol prior to placement of DBS. The patient will subsequently undergo standard-of-care therapy for DBS placement. Once the stimulator has been programmed post-operatively, the stimulation parameters and corresponding clinical changes will be collected and used to model the volume of activated tissue. The patient will additionally undergo a follow-up MRI used to localize the electrode within the brain to further localize the volume of activated tissue.
Intervention: DBS Programming (Device)
Outcomes
Primary Outcomes
Change in Unified Parkinson's Disease Rating Scale III (UPDRS-III)
Time Frame: 3 months
Pre-operative and post-operative UPDRS-III will be assessed to measure symptom improvement and correlated with imaging data.
Secondary Outcomes
No secondary outcomes reported
Investigators
Erik H. Middlebrooks, M.D.
Assistant Professor, Radiology and Neurosurgery
Mayo Clinic