Back to resultsA Study to Evaluate fMRI of Active DBS Stimulation in Epilepsy
Primary Purpose
Refractory Epilepsy
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Functional magnetic resonance imaging (fMRI)
Sponsored by
About this trial
This is an interventional basic science trial for Refractory Epilepsy focused on measuring Deep Brain Stimulation
Eligibility Criteria
Inclusion Criteria:
- Patients who have previously undergone anterior thalamic nucleus deep brain stimulation (DBS) for refractory epilepsy.
Exclusion Criteria:
- Contraindication to MRI; prior brain resective surgery or large area of brain tissue loss (e.g., large area infarction).
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Anterior Nucleus of the Thalamus (ANT) Deep Brain Stimulation (DBS)
Arm Description
Subjects that have undergone DBS placement for treatment of refractory epilepsy will undergo a fMRI scan. During the fMRI, the subject will undergo alternating short periods of their DBS in the "on" and "off" state with high- and low frequency settings to measure the brain activation changes induced by the DBS.
Outcomes
Primary Outcome Measures
Document brain activation networks with ANT stimulation
Use resting state fMRI to map brain network activation with high and low frequency of ANT stimulation.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04753983
Brief Title
A Study to Evaluate 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
October 2022
Overall Recruitment Status
Withdrawn
Why Stopped
No longer have funding
Study Start Date
September 2022 (Anticipated)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)
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
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to use functional imaging to study the mechanisms of the anterior nucleus of the thalamus (ANT) deep brain stimulation (DBS).
Detailed Description
Researchers are testing how changing the settings on deep brain stimulation device (DBS) can help reduce the number and severity of seizures. Functional imaging will be used to study the mechanisms of ANT DBS to optimize the device settings to improve the degree of seizure reduction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory 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
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Anterior Nucleus of the Thalamus (ANT) Deep Brain Stimulation (DBS)
Arm Type
Experimental
Arm Description
Subjects that have undergone DBS placement for treatment of refractory epilepsy will undergo a fMRI scan. During the fMRI, the subject will undergo alternating short periods of their DBS in the "on" and "off" state with high- and low frequency settings to measure the brain activation changes induced by the DBS.
Intervention Type
Diagnostic Test
Intervention Name(s)
Functional magnetic resonance imaging (fMRI)
Intervention Description
Diagnostic imaging measuring the metabolic changes that occur within the brain used for measuring and mapping brain activity
Primary Outcome Measure Information:
Title
Document brain activation networks with ANT stimulation
Description
Use resting state fMRI to map brain network activation with high and low frequency of ANT stimulation.
Time Frame
Results would be available immediately following processing of the imaging data after each scan
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- Patients who have previously undergone anterior thalamic nucleus deep brain stimulation (DBS) for refractory epilepsy.
Exclusion Criteria:
- Contraindication to MRI; prior brain resective surgery or large area of brain tissue loss (e.g., large area infarction).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven A Messina, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
A Study to Evaluate fMRI of Active DBS Stimulation in Epilepsy
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