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Clinical Trials/NCT06575413
NCT06575413
Completed
Not Applicable

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

Xuanwu Hospital, Beijing1 site in 1 country8 target enrollmentMay 27, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Refractory Epilepsy
Sponsor
Xuanwu Hospital, Beijing
Enrollment
8
Locations
1
Primary Endpoint
Patients Clinical responses Rating
Status
Completed
Last Updated
9 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 27, 2024
End Date
March 5, 2025
Last Updated
9 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Liankun_Ren

Professor

Xuanwu Hospital, Beijing

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Subjects that experience surgical complications during the implant procedure will be excluded from the study

Outcomes

Primary Outcomes

Patients Clinical responses Rating

Time Frame: During 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 bands

Time Frame: During 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 Potentials

Time Frame: During 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.

Study Sites (1)

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