Electrophysiological Biomarkers in MTLE Patients.

Mesial Temporal Lobe Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04710004
• Other study ID #: STUDY00001554
• Status: Terminated
• Phase: N/A
• Start date: November 30, 2021
• Est. completion date: December 16, 2021

Study information

• Verified date: March 2024
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: December 16, 2021
• Est. primary completion date: December 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy
• Epilepsy, Temporal Lobe
• Mesial Temporal Lobe Epilepsy

Intervention

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.

Locations

Country	Name	City	State
United States	Epilepsy monitoring unit (EMU) at Emory University Hospital	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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