Advancing Pre-operative Targeting for Deep Brain Stimulation in the Globus Pallidus Internus

Not Applicable

Terminated

• Conditions: Parkinson Disease
• Interventions: Device: DBS Programming

• Registration Number: NCT03600740
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-17
• Study First Submitted QC: 2018-07-17
• Study First Posted: 2018-07-26
• Study Start: 2018-08-17
• Primary Completion: 2020-05-18
• Study Completion: 2020-05-18
• Status Verified: 2021-04
• Results First Submitted: 2021-04-03
• Results First Submitted QC: 2021-04-03
• Last Update Submitted: 2021-04-03
• Results First Posted: 2021-04-29
• Last Update Posted: 2021-04-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GPi DBS	DBS Programming	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.

Primary Outcome Measures

Name	Time	Method
Change in Unified Parkinson's Disease Rating Scale III (UPDRS-III)	3 months	Pre-operative and post-operative UPDRS-III will be assessed to measure symptom improvement and correlated with imaging data.

Trial Locations

Locations (3)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States