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

NCT03600740 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2021-04-29

Study results available
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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.

Conditions

  • Parkinson Disease

Interventions

DEVICE

DBS Programming

DBS Programming may be temporarily altered based on imaging data to measure a change in clinical symptoms.

Sponsors & Collaborators

Principal Investigators

  • Erik H Middlebrooks · Mayo Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-17
Primary Completion
2020-05-18
Completion
2020-05-18
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03600740 on ClinicalTrials.gov