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
• Status: Terminated
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• Parkinson Disease

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

External Links

•   Mayo Clinic Clinical Trials