Electrophysiological Biomarkers in MTLE Patients.

Emory University

Status: Terminated

Conditions: Mesial Temporal Lobe Epilepsy

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04710004

STUDY00001554

Details and patient eligibility

About

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.

Full 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).

Enrollment: 1 patient

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Brain stimulation via clinically implanted electrodes

Experimental group

Description:

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

Treatment:

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