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NCT03600740 Clinical Trial

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

Parkinson Disease Clinical Trial

Official title:
Advancing Pre-operative Targeting for Deep Brain Stimulation in the Globus Pallidus Internus: Functional Segmentation Based on Probabilistic Tractography

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03600740
Other study ID # 18-002176
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date August 17, 2018
Est. completion date May 18, 2020

Study information
Verified date April 2021
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 1
Est. completion date May 18, 2020
Est. primary completion date May 18, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Patient with the diagnosis of Parkinson's Disease selected for placement of globus pallidus internus (GPi) deep brain stimulator (DBS)

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Mayo Clinic in Florida Jacksonville Florida
United States Mayo Clinic in Rochester Rochester Minnesota
United States Mayo Clinic in Arizona Scottsdale Arizona

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Unified Parkinson's Disease Rating Scale III (UPDRS-III) Pre-operative and post-operative UPDRS-III will be assessed to measure symptom improvement and correlated with imaging data. 3 months
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