Electrophysiological Biomarkers in MTLE Patients.

NCT04710004 | Terminated Results DMC FDA Device

• 1 other identifier: STUDY00001554
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Mesial Temporal Lobe Epilepsy

Keywords

Epilepsy; Biomarkers

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Changes in Memory During Brain Stimulation From Baseline

  Baseline, up to 6 weeks postintervention

Study Arms (1)

Brain stimulation via clinically implanted electrodes

EXPERIMENTAL

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

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

Interventions

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

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

Also known as: ADMES

Brain stimulation via clinically implanted electrodes

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Any patient who is unwilling or unable to provide consent
• Women who are pregnant
• Patients under 18 years
• Incarcerated persons

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Epilepsy monitoring unit (EMU) at Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Dr. Robert Gross
• Organization: Emory University

rgross@emory.edu

404-727-2354

Study Officials

• Robert Gross, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 14, 2021
• Study Start: November 30, 2021
• Primary Completion: December 16, 2021
• Study Completion: December 16, 2021
• Last Updated: March 5, 2024
• Results First Posted: March 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)