Back to resultsElectrophysiological Biomarkers in MTLE Patients.
Primary Purpose
Mesial Temporal Lobe Epilepsy
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Asynchronous distributed multi-electrode stimulation (ADMES) using an implantable neurostimulation device
Sponsored by
About this trial
This is an interventional basic science trial for Mesial Temporal Lobe Epilepsy focused on measuring Epilepsy, Biomarkers
Eligibility Criteria
Inclusion Criteria:
- Provision of signed and dated informed consent form
- Male or female, aged 18-65
- Diagnosed with lesional or non-lesional mesial temporal (hippocampal) seizure onset confirmed on SEEG monitoring
- Implanted with depth electrodes for localization of seizure onset with multiple hippocampal electrode arrays
Exclusion criteria:
- Any patient who is unwilling or unable to provide consent
- Women who are pregnant
- Patients under 18 years
- Incarcerated persons
Sites / Locations
- Epilepsy monitoring unit (EMU) at Emory University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Brain stimulation via clinically implanted electrodes
Arm Description
Brain will be stimulated in different patterns including synchronized or asynchronous current.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04710004
Brief Title
Electrophysiological Biomarkers in MTLE Patients.
Official Title
Electrophysiological Biomarkers During Invasive Monitoring of Mesial Temporal Lobe Epilepsy Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 30, 2021 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mesial Temporal Lobe Epilepsy
Keywords
Epilepsy, Biomarkers
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Brain stimulation via clinically implanted electrodes
Arm Type
Experimental
Arm Description
Brain will be stimulated in different patterns including synchronized or asynchronous current.
Intervention Type
Device
Intervention Name(s)
Asynchronous distributed multi-electrode stimulation (ADMES) using an implantable neurostimulation device
Other Intervention Name(s)
ADMES
Intervention Description
Participants will receive asynchronous pulses distributed across a multi-electrode array of 16 micro-electrodes and stimulating at low (theta) frequencies.
Primary Outcome Measure Information:
Title
Change in Intracranial EEG recording: spectral power from baseline
Description
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.
Time Frame
Baseline, up to 6 weeks postintervention
Title
Change in Intracranial EEG recording: synchrony from baseline
Description
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.
Time Frame
Baseline, up to 6 weeks postintervention
Secondary Outcome Measure Information:
Title
Changes in memory during brain stimulation from baseline
Description
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.
Time Frame
Baseline, up to 6 weeks postintervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Provision of signed and dated informed consent form
Male or female, aged 18-65
Diagnosed with lesional or non-lesional mesial temporal (hippocampal) seizure onset confirmed on SEEG monitoring
Implanted with depth electrodes for localization of seizure onset with multiple hippocampal electrode arrays
Exclusion criteria:
Any patient who is unwilling or unable to provide consent
Women who are pregnant
Patients under 18 years
Incarcerated persons
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robert Gross, MD
Phone
404-778-5770
Email
rgross@emory.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Gross, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Epilepsy monitoring unit (EMU) at Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
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Electrophysiological Biomarkers in MTLE Patients.
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