NCT07912931Not yet recruiting
Electrophysiological Dose-Response to Anterior Thalamic Deep Brain Stimulation in Drug-Resistant Focal Epilepsy
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
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 28 Oct 2026
- Start date
- 1 Nov 2026
- Primary completion date
- 31 May 2028
- Lead sponsor
- Yonsei University
- Diseases
- Epilepsy
- NCT number
- NCT07912931
What you commit to
- Study type: Interventional
- Planned participants: 10
- From 1 Nov 2026 to the primary completion date, 31 May 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Any other medical condition that, in the investigator's judgment, makes participation inappropriate
Other
- Implantation planned with a lead or device without sensing capability
- Pregnant or planning pregnancy
- Unable to understand or cooperate with study procedures
Who the study is looking for
- 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
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Severance hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.