A Study to Evaluate fMRI of Active DBS Stimulation in Epilepsy

• Sponsor: Mayo Clinic (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04753983
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 20
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Refractory Epilepsy	Diagnostic Test: Functional magnetic resonance imaging (fMRI)	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 10 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
• Anticipated Study Start Date: Sep 1, 2022
• Anticipated Primary Completion Date: May 1, 2024
• Anticipated Study Completion Date: May 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic

Investigators

• Principal Investigator: Steven A Messina, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: Steven A. Messina, Principal Investigator, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT04753983
• Other Study ID Numbers: 20-006464
• First Posted: Feb 15, 2021
• Last Update Posted: Aug 16, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Steven A. Messina, Principal Investigator, Mayo Clinic: Deep Brain Stimulation
• Additional relevant MeSH terms: Epilepsy; Drug Resistant Epilepsy

Study Results

No Results Posted as of Aug 16, 2022