Back to resultsfMRI of Active DBS Stimulation in Epilepsy
Primary Purpose
Epilepsy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Functional MRI
Sponsored by
About this trial
This is an interventional basic science trial for Epilepsy focused on measuring Deep Brain Stimulation
Eligibility Criteria
Inclusion Criteria
- Patients selected to undergo anterior thalamic nucleus DBS for refractory epilepsy
Exclusion Criteria
- Contraindication to MRI
Sites / Locations
- Mayo Clinic in Florida
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Deep Brain Stimulation subjects
Arm Description
Outcomes
Primary Outcome Measures
DBS Stimulation
The primary endpoint of this feasibility study is detection of functional MRI activation related to DBS stimulation.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03870308
Brief Title
fMRI of Active DBS Stimulation in Epilepsy
Official Title
fMRI of Active DBS Stimulation in Epilepsy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
March 5, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
January 11, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Researchers are trying to incorporate a process known as Functional MRI (fMRI) scanning to reveal a pattern in brain activity during Deep Brain Stimulation (DBS), which will correlate to possible seizure freedom.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Deep Brain Stimulation
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Deep Brain Stimulation subjects
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
Functional MRI
Intervention Description
A special type of MRI measuring the metabolic changes that occur within the brain. It may be used to examine the brain's anatomy and determine which parts of the brain are handling critical functions. It helps identify important language and movement control areas in the brain.
Primary Outcome Measure Information:
Title
DBS Stimulation
Description
The primary endpoint of this feasibility study is detection of functional MRI activation related to DBS stimulation.
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Patients selected to undergo anterior thalamic nucleus DBS for refractory epilepsy
Exclusion Criteria
Contraindication to MRI
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erik H Middlebrooks
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
fMRI of Active DBS Stimulation in Epilepsy
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