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

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.

Study Overview

• Status: Completed
• Conditions: Refractory Epilepsy; Consciousness, Loss of
• Intervention / Treatment: Other: Direct Electrical Stimulation

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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100053
      • Xuanwu Hospital,Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Direct electrical stimulation of the Claustrum; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients Clinical responses Rating	Researchers categorized patients' clinical responses as normal, mild, moderate, or severe based on their subjective clinical response.	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)	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.	During the trial(up to 3 hours for each subject)

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing
• Investigators: Principal Investigator: Liankun Ren, Xuanwu Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2024
• Primary Completion (Actual): December 30, 2024
• Study Completion (Actual): March 5, 2025

Study Registration Dates

• First Submitted: August 16, 2024
• First Submitted That Met QC Criteria: August 26, 2024
• First Posted (Actual): August 28, 2024

Study Record Updates

• Last Update Posted (Actual): July 11, 2025
• Last Update Submitted That Met QC Criteria: July 8, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Consciousness; Refractory Epilepsy; Claustrum
• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurobehavioral Manifestations; Consciousness Disorders; Drug Resistant Epilepsy; Epilepsy; Unconsciousness
• Other Study ID Numbers: 2024-125-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No