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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. Read our disclaimer for details. Identifier: NCT03870308
Recruitment Status : Completed
First Posted : March 12, 2019
Last Update Posted : September 17, 2021
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)
Actual Enrollment : 6 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
Actual Primary Completion Date : December 31, 2020
Actual Study Completion Date : January 11, 2021

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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 identifier (NCT number): NCT03870308

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United States, Florida
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
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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 Identifier: NCT03870308    
Other Study ID Numbers: 18-010321
First Posted: March 12, 2019    Key Record Dates
Last Update Posted: September 17, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Erik H. Middlebrooks, M.D., Mayo Clinic:
Deep Brain Stimulation
Additional relevant MeSH terms:
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Brain Diseases
Central Nervous System Diseases
Nervous System Diseases