Electrophysiological Biomarkers in MTLE Patients.

NCT ID: NCT04710004

Last Updated: 2024-03-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-30
• Study Completion Date: 2021-12-16

Brief Summary

The investigators plan to enroll individuals with medical temporal lobe epilepsy who are undergoing surgical workup with clinically implanted intracranial electrodes. The study intends to administer computerized memory tasks and stimulation during the intracranial Electroencephalography (EEG) monitoring period.

Detailed Description

This is a nonrandomized interventional trial that will apply brain stimulation via clinically implanted intracranial electrodes to subjects with medial temporal lobe epilepsy with the purpose of identifying biomarkers related to the pre-ictal state; to perform an acute parameter search to determine the stimulation pattern that most effectively modifies these biomarkers and to identify changes in memory (free recall) during asynchronous distributed multi-electrode stimulation (ADMES).

Conditions

Mesial Temporal Lobe Epilepsy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Brain stimulation via clinically implanted electrodes

Brain will be stimulated in different patterns including synchronized or asynchronous current.

Group Type: EXPERIMENTAL

Asynchronous distributed multi-electrode stimulation (ADMES) using an implantable neurostimulation device

Intervention Type: DEVICE

Participants will receive asynchronous pulses distributed across a multi-electrode array of 16 micro-electrodes and stimulating at low (theta) frequencies.

Interventions

Asynchronous distributed multi-electrode stimulation (ADMES) using an implantable neurostimulation device

Participants will receive asynchronous pulses distributed across a multi-electrode array of 16 micro-electrodes and stimulating at low (theta) frequencies.

Intervention Type: DEVICE

Other Intervention Names

ADMES

Eligibility Criteria

Inclusion Criteria

1. Provision of signed and dated informed consent form

2. Male or female, aged 18-65

3. Diagnosed with lesional or non-lesional mesial temporal (hippocampal) seizure onset confirmed on SEEG monitoring

4. Implanted with depth electrodes for localization of seizure onset with multiple hippocampal electrode arrays

Exclusion Criteria

1. Any patient who is unwilling or unable to provide consent

2. Women who are pregnant

3. Patients under 18 years

4. Incarcerated persons

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Robert Gross

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert Gross, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Epilepsy monitoring unit (EMU) at Emory University Hospital

Atlanta, Georgia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

STUDY00001554

Identifier Type: -

Identifier Source: org_study_id