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

NCT03600740 | Terminated Results FDA Device

• 1 other identifier: 18-002176
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 3

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.

Conditions

Parkinson Disease

Keywords

Parkinson Disease; Deep Brain Stimulation; Diffusion Tensor Imaging

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

GPi DBS

EXPERIMENTAL

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.

Device: DBS Programming

Interventions

DBS Programming DEVICE

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

GPi DBS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Patient with the diagnosis of Parkinson's Disease selected for placement of globus pallidus internus (GPi) deep brain stimulator (DBS)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (3)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Limitations and Caveats

Study was terminated due to delays in IRB approval and interval start of a competing study. Surgical plan was altered-subject not eligible. Data was not collected or analyzed.

Results Point of Contact

• Title: Erik H. Middlebrooks, M.D.
• Organization: Mayo Clinic

Middlebrooks.Erik@mayo.edu

904-953-6696

Study Officials

• Erik H Middlebrooks

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Radiology and Neurosurgery

Study Record Dates

• First Submitted: July 17, 2018
• First Posted: July 26, 2018
• Study Start: August 17, 2018
• Primary Completion: May 18, 2020
• Study Completion: May 18, 2020
• Last Updated: April 29, 2021
• Results First Posted: April 29, 2021

Record last verified: 2021-04

Locations

US (3)