Electrophysiological Biomarkers in MTLE Patients.

Electrophysiological Biomarkers During Invasive Monitoring of Mesial Temporal Lobe Epilepsy Patients.

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.

Study Overview

• Status: Terminated
• Conditions: Mesial Temporal Lobe Epilepsy
• Intervention / Treatment: Device: Asynchronous distributed multi-electrode stimulation (ADMES) using an implantable neurostimulation device

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).

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Epilepsy monitoring unit (EMU) at Emory University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Brain stimulation via clinically implanted electrodes; Brain will be stimulated in different patterns including synchronized or asynchronous current.	Device: 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.; Other Names: ADMES

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Intracranial EEG Recording: Spectral Power From Baseline	Spectral power will be compared between baseline/sham and stimulation trials to determine if asynchronous stimulation modulates spectral power during the preictal, ictal or post ictal states. Spectral power is measured in microvolts. A change in either direction from baseline is associated with a better outcome.	Baseline, up to 6 weeks postintervention
Change in Intracranial EEG Recording: Synchrony From Baseline	Synchrony will be compared between baseline/sham and stimulation trials to determine if asynchronous stimulation modulates synchrony during the preictal, ictal or post ictal states. Synchrony is a measure of how any pair of regions communicate with one another. Synchrony is measured as the correlation [-1 to 1] between two time series. The investigators anticipate that a decrease in synchrony (correlation approaching 0) is associated with improved outcome.	Baseline, up to 6 weeks postintervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Memory During Brain Stimulation From Baseline	Patients will be asked to recall a list of words after a 20-second delay in which they will do simple math problems to ensure long-term memory encoding. Three ~1-2-hour sessions will be performed; each session will consist of 24 free recall tasks (12 during ADMES and 12 with no stimulation). The memory score will be assessed as the percentage correct out of 12. The higher the percentage recalled, the better the score.	Baseline, up to 6 weeks postintervention

Collaborators and Investigators

• Sponsor: Emory University
• Investigators: Principal Investigator: Robert Gross, MD, Emory University

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2021
• Primary Completion (Actual): December 16, 2021
• Study Completion (Actual): December 16, 2021

Study Registration Dates

• First Submitted: January 13, 2021
• First Submitted That Met QC Criteria: January 13, 2021
• First Posted (Actual): January 14, 2021

Study Record Updates

• Last Update Posted (Estimated): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Epilepsy; Biomarkers
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epileptic Syndromes; Epilepsies, Partial; Epilepsy; Epilepsy, Temporal Lobe
• Other Study ID Numbers: STUDY00001554

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No