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Investigating the Role and Electrophysiological Characteristics of the Human Claustrum Based on SEEG

Investigating the Role and Electrophysiological Characteristics of the Human Claustrum Based on SEEG

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06575413
Enrollment
8
Registered
2024-08-28
Start date
2024-05-27
Completion date
2025-03-05
Last updated
2025-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Consciousness, Loss of, Refractory Epilepsy

Keywords

Refractory Epilepsy, Consciousness, Claustrum

Brief summary

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.

Detailed description

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.

Interventions

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.

Sponsors

Xuanwu Hospital, Beijing
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
14 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

1. The patients were diagnosed with drug-resistant epilepsy. 2. The patients underwent stereoelectroencephalography (SEEG) implantation for pre-surgical evaluation of epilepsy, with at least one electrode target reaching the claustrum 3. Participants/parents/legal guardian provide informed consent for inclusion

Exclusion criteria

1\. Subjects that experience surgical complications during the implant procedure will be excluded from the study

Design outcomes

Primary

MeasureTime frameDescription
Patients Clinical responses RatingDuring the trial(up to 3 hours for each subject)Researchers categorized patients' clinical responses as normal, mild, moderate, or severe based on their subjective clinical response.
EEG power in spectral frequency bandsDuring the trial(up to 3 hours for each subject)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)
The root mean square (RMS) value of Claustrum-Cortical Evoked PotentialsDuring the trial(up to 3 hours for each subject)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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 6, 2026