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NCT04753983 Clinical Trial

A Study to Evaluate fMRI of Active DBS Stimulation in Epilepsy

Refractory Epilepsy Clinical Trial

Official title:
fMRI of Active DBS Stimulation in Epilepsy

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT04753983
Other study ID # 20-006464
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date September 2022
Est. completion date May 2024

Study information
Verified date October 2022
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date May 2024
Est. primary completion date May 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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).

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Functional magnetic resonance imaging (fMRI)
Diagnostic imaging measuring the metabolic changes that occur within the brain used for measuring and mapping brain activity

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Outcome
Type Measure Description Time frame Safety issue
Primary Document brain activation networks with ANT stimulation Use resting state fMRI to map brain network activation with high and low frequency of ANT stimulation. Results would be available immediately following processing of the imaging data after each scan
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