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Electrophysiological Dose-Response to Anterior Thalamic Deep Brain Stimulation in Drug-Resistant Focal Epilepsy
Sponsor: Yonsei University
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
INTERVENTIONAL
Enrollment
10
Start Date
2026-11
Completion Date
2029-02
Last Updated
2026-11-03
Healthy Volunteers
No
Conditions
Interventions
Anterior thalamic deep brain stimulation with a standardized amplitude schedule and acute stimulation challenges
ANT-DBS implantation using the sensing-enabled Medtronic Percept PC is standard care, independent of study participation. Study-specific procedures include scheduled chronic stimulation (145 Hz, 90 μs, cycling) at 2.0 mA from activation and 3.5 mA from month 1, with clinical adjustments permitted. At month 3, the physician selects 3.0-4.0 mA, followed by routine management. Acute challenges at activation, month 1, and month 3 test 2.0 mA; 2.0/3.5 mA; and 2.0/3.5/up to 5.0 mA, respectively. Each amplitude is repeated at least twice, with counterbalanced sequences at months 1 and 3. Each block includes a 2-minute local stimulation-OFF baseline, continuous stimulation with 60 seconds of stable LFP recording at the target amplitude, and at least 5 minutes of OFF washout between blocks. If bilateral 5.0 mA is not tolerated, the maximum common tolerated amplitude is used. Challenges may be modified or stopped for safety.
Locations (1)
Severance Hospital
Seoul, South Korea