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

• Sponsor: Mayo Clinic (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03600740
• Collaborator: (none)
• Enrollment: 1
• Locations: 3
• Arm: 1
• Actual Duration (Months): 21
• Patients Per Site: 0.3
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease	Device: DBS Programming	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 1 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Advancing Pre-operative Targeting for Deep Brain Stimulation in the Globus Pallidus Internus: Functional Segmentation Based on Probabilistic Tractography
• Actual Study Start Date: Aug 17, 2018
• Actual Primary Completion Date: May 18, 2020
• Actual Study Completion Date: May 18, 2020

Arms and Interventions

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Arizona	Scottsdale	Arizona	United States	85259
2	Mayo Clinic in Florida	Jacksonville	Florida	United States	32224
3	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic

Investigators

• Principal Investigator: Erik H Middlebrooks, Mayo Clinic

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 21, 2018

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: Erik H. Middlebrooks, M.D., Assistant Professor, Radiology and Neurosurgery, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT03600740
• Other Study ID Numbers: 18-002176
• First Posted: Jul 26, 2018
• Last Update Posted: Apr 29, 2021
• Last Verified: Apr 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Erik H. Middlebrooks, M.D., Assistant Professor, Radiology and Neurosurgery, Mayo Clinic: Parkinson Disease; Deep Brain Stimulation; Diffusion Tensor Imaging
• Additional relevant MeSH terms: Parkinson Disease

Study Results

Participant Flow

Arm/Group Title	GPi DBS
Arm/Group Description	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. DBS Programming: DBS Programming may be temporarily altered based on imaging data to measure a change in clinical symptoms.
Period Title: Overall Study
STARTED	1
COMPLETED	0
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	GPi DBS
Arm/Group Description	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. DBS Programming: DBS Programming may be temporarily altered based on imaging data to measure a change in clinical symptoms.
Overall Participants	1
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	0 0%
>=65 years	1 100%
Sex: Female, Male (Count of Participants)
Female	1 100%
Male	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	1 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	1 100%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	1 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	GPi DBS
Arm/Group Description	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. DBS Programming: DBS Programming may be temporarily altered based on imaging data to measure a change in clinical symptoms.
Measure Participants	0

Adverse Events

Time Frame	Adverse Events were collected from baseline to end of study, approximately 1 week
Arm/Group Title	GPi DBS
Arm/Group Description	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. DBS Programming: DBS Programming may be temporarily altered based on imaging data to measure a change in clinical symptoms.
All Cause Mortality
	GPi DBS
	Affected / at Risk (%)	# Events
Total	0/1 (0%)
Serious Adverse Events
	GPi DBS
	Affected / at Risk (%)	# Events
Total	0/1 (0%)
Other (Not Including Serious) Adverse Events
	GPi DBS
	Affected / at Risk (%)	# Events
Total	0/1 (0%)

Limitations/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.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.