A Study to Evaluate fMRI of Active DBS Stimulation in Epilepsy

Not Applicable

Withdrawn

• Conditions: Refractory Epilepsy
• Interventions: Diagnostic Test: Functional magnetic resonance imaging (fMRI)

• Registration Number: NCT04753983
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study First Submitted: 2021-02-09
• Study First Submitted QC: 2021-02-09
• Study First Posted: 2021-02-15
• Study Start: 2022-09
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-28
• Last Update Posted: 2022-11-01
• Primary Completion: 2024-05
• Study Completion: 2024-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patients who have previously undergone anterior thalamic nucleus deep brain stimulation (DBS) for refractory epilepsy.

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Exclusion Criteria

• Contraindication to MRI; prior brain resective surgery or large area of brain tissue loss (e.g., large area infarction).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Anterior Nucleus of the Thalamus (ANT) Deep Brain Stimulation (DBS)	Functional magnetic resonance imaging (fMRI)	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.

Primary Outcome Measures

Name	Time	Method
Document brain activation networks with ANT stimulation	Results would be available immediately following processing of the imaging data after each scan	Use resting state fMRI to map brain network activation with high and low frequency of ANT stimulation.