A Study to Evaluate fMRI of Active DBS Stimulation in Epilepsy

NCT ID: NCT04753983

Last Updated: 2022-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-30

Study Completion Date

2024-05-31

Brief Summary

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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

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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.

Conditions

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Refractory Epilepsy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Anterior Nucleus of the Thalamus (ANT) Deep Brain Stimulation (DBS)

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.

Group Type EXPERIMENTAL

Functional magnetic resonance imaging (fMRI)

Intervention Type DIAGNOSTIC_TEST

Diagnostic imaging measuring the metabolic changes that occur within the brain used for measuring and mapping brain activity

Interventions

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Functional magnetic resonance imaging (fMRI)

Diagnostic imaging measuring the metabolic changes that occur within the brain used for measuring and mapping brain activity

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Steven A. Messina

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Steven A Messina, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Related Links

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Other Identifiers

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20-006464

Identifier Type: -

Identifier Source: org_study_id

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