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Tests thalamic brain stimulation strength on brain signals in drug-resistant focal epilepsy

Studies how stimulation strength changes brain signals in adults with drug-resistant epilepsy.

Plain-language title generated from the registry record
Registry title: Electrophysiological Dose-Response to Anterior Thalamic Deep Brain Stimulation in Drug-Resistant Focal Epilepsy

Key facts

Where
Seoul, South KoreaSee the site

Where in South Korea

  • Severance hospitalSeoul, South KoreaNo longer taking part

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Trial details

Who runs it
Yonsei University
Trial code
NCT07912931
Record updated
3 November 2026
Original description
This prospective, single-center mechanistic pilot study will investigate the electrophysiological dose-response to anterior thalamic deep brain stimulation (ANT-DBS) in 10 adults with drug-resistant focal epilepsy undergoing clinically indicated DBS implantation.Read full original descriptionShow less

Electric-Field-Informed Network Engagement, Acute Electrophysiological Dose Response, Chronic Neural Adaptation, and Long-Term Seizure Response to Anterior Thalamic Deep Brain Stimulation in Drug-Resistant Epilepsy: A Prospective Mechanistic Pilot Study

This prospective, single-center mechanistic pilot study will investigate the electrophysiological dose-response to anterior thalamic deep brain stimulation (ANT-DBS) in 10 adults with drug-resistant focal epilepsy undergoing clinically indicated DBS implantation.

Using local field potentials (LFPs) recorded from implanted sensing-enabled DBS leads, investigators will assess stimulation-induced changes in slow-gamma (20-50 Hz) power. Standardized acute stimulation challenges will be performed at DBS activation (2.0 mA), 1 month after activation (2.0 and 3.5 mA), and 3 months after activation (2.0, 3.5, and up to 5.0 mA, as tolerated). Each amplitude will be tested at least twice against a stimulation-OFF baseline.

The primary objective is to characterize the amplitude-dependent electrophysiological response, with the hypothesis that higher stimulation amplitudes produce greater slow-gamma suppression. Secondary objectives include assessing response reproducibility, characterizing longitudinal LFP adaptation during the first 3 months, investigating associations with electrode location and modeled electric fields, and exploring relationships with seizure-frequency reduction during months 7-12 after stimulation activation.

Inclusion: Age 19 years or older; Drug-resistant focal epilepsy that has not responded to three or more antiseizure medications, with bilateral anterior thalamic DBS using a sensing-enabled device scheduled as part of standard care; Able to cooperate with study participation, repeated visits, questionnaires and tests; Understands the purpose and procedures of the study and provides written informed consent.

Exclusion: Any other medical condition that, in the investigator's judgment, makes participation inappropriate; Implantation planned with a lead or device without sensing capability; Pregnant or planning pregnancy; Unable to understand or cooperate with study procedures.

ClinicalTrials.gov NCT07912931