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fMRI of Active DBS Stimulation in Epilepsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03870308
Recruitment Status : Recruiting
First Posted : March 12, 2019
Last Update Posted : April 13, 2020
Sponsor:
Information provided by (Responsible Party):
Erik H. Middlebrooks, M.D., Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Epilepsy Diagnostic Test: Functional MRI Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: fMRI of Active DBS Stimulation in Epilepsy
Actual Study Start Date : March 5, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arm Intervention/treatment
Experimental: Deep Brain Stimulation subjects Diagnostic Test: Functional MRI
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 Measures :
  1. DBS Stimulation [ Time Frame: One year ]
    The primary endpoint of this feasibility study is detection of functional MRI activation related to DBS stimulation.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Patients selected to undergo anterior thalamic nucleus DBS for refractory epilepsy

Exclusion Criteria

  • Contraindication to MRI

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03870308


Locations
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United States, Florida
Mayo Clinic in Florida Recruiting
Jacksonville, Florida, United States, 32224
Contact: Kendra Brown    904-953-7755    brown.kendra@mayo.edu   
Principal Investigator: Erik Middlebrooks         
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Erik H Middlebrooks Mayo Clinic
Additional Information:
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Responsible Party: Erik H. Middlebrooks, M.D., Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03870308    
Other Study ID Numbers: 18-010321
First Posted: March 12, 2019    Key Record Dates
Last Update Posted: April 13, 2020
Last Verified: April 2020

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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., Mayo Clinic:
Deep Brain Stimulation
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases