An interventional study of Direct Electrical Stimulation in Refractory Epilepsy and Consciousness, Loss of, sponsored by Xuanwu Hospital, Beijing. Completed at 1 site in China. Open to participants aged 14 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-07-11.
Sponsored by Xuanwu Hospital, Beijing · Not applicable, Interventional, and Basic science
This single-center prospective study aims to investigate the electrophysiological characteristics and functions of the human claustrum by analyzing clinical, imaging, and electrophysiological data from 14\~65-year-old patients with drug-resistant epilepsy.
Stereoelectroencephalography (SEEG) is a method for recording electrical activity from deep brain structures using implanted depth electrodes to provide a three-dimensional view of neuronal activity.
Direct Electrical Stimulation (DES) is a neurosurgical technique that involves delivering electrical impulses to specific brain regions through implanted electrodes to map critical functional areas and to study the connectivity of brain regions.
This study aims to investigate the electrophysiological characteristics and functions of the human claustrum by analyzing clinical, imaging, and electrophysiological data from patients aged 14 to 65 implanted intracranial electrodes , with a specific focus on electrodes targeting the claustrum. This research forms part of a broader initiative to explore the functions of cortical and subcortical regions based on SEEG.
261 studies on the registry are indexed under Drug Resistant Epilepsy; 99 are open to participants now.
This study's enrollment of 8 is below the median of 30 across 208 interventional studies indexed under Drug Resistant Epilepsy.
Browse Drug Resistant Epilepsy studies →Xuanwu Hospital, Beijing is the lead sponsor of 346 studies on the registry; 217 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
1. Subjects that experience surgical complications during the implant procedure will be excluded from the study
The investigators performed direct electrical stimulation of the claustrum in drug-resistant epilepsy patients underwent SEEG monitoring.The investigators observed the neural activities before, during, and after stimulation and the claustrum-cortical network to figure out the role of claustrum in consciousness and its underlying electrophysiological mechanism.
Other: Direct Electrical Stimulation
The patients underwent SEEG with at least one electrode targeting the claustrum. The investigators used the claustrum as a target for both mapping and CCEP, recording changes in cortical electrical activity.
Patients Clinical responses Rating
Researchers categorized patients' clinical responses as normal, mild, moderate, or severe based on their subjective clinical response.
Time frame: During the trial(up to 3 hours for each subject)
EEG power in spectral frequency bands
Using SEEG-implanted electrodes, the investigators applied electrical stimulation of varying intensities to the CLA while observing and recording EEG power changes across six spectral frequency bands during the pre-stimulation, stimulation, and post-stimulation periods. EEG Frequency Bands * delta (1-4 Hz) * theta (5-8 Hz) * alpha (9-12 Hz) * beta (13-30 Hz) * low gamma (31-70 Hz) * high gamma (71-150 Hz)
Time frame: During the trial(up to 3 hours for each subject)
The root mean square (RMS) value of Claustrum-Cortical Evoked Potentials
All cortical-evoked responses were averaged by time-locking the recordings to the onset of each electrical stimulus (zero) off-line, within a time window of -200 to +400 mses, to quantify the morphology. The N1 peak, identified as the first negative deflection distinguishable from the stimulus artifact, was the primary focus due to its clear visibility and reproducibility across different stimulations. The root mean square (RMS) value will be calculated for different cortical locations during time windows that encompass both the N1 peak(early response time time window) and the baseline. A paired one-sample t-test will be used to compare the RMS values in the early response time window across different cortical sites with the RMS values in the baseline.
Time frame: During the trial(up to 3 hours for each subject)
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Xuanwu Hospital, Beijing