NCT04710004

Electrophysiological Biomarkers in MTLE Patients.

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Mesial Temporal Lobe Epilepsy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-11-30
• Primary completion: 2021-12-16
• Completion: 2021-12-16
• First posted: 2021-01-14
• Last updated: 2024-03-05
• Results posted: 2024-03-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study