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

NCT06575413 | Completed

• 1 other identifier: 2024-125-001
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Refractory Epilepsy; Consciousness, Loss of

Keywords

Refractory Epilepsy; Consciousness; Claustrum

Outcome Measures

Primary Outcomes (3)

• 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)

Study Arms (1)

Direct electrical stimulation of the Claustrum

EXPERIMENTAL

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

Interventions

Direct Electrical Stimulation OTHER

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.

Direct electrical stimulation of the Claustrum

Eligibility Criteria

• Age: 14 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital,Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location

MeSH Terms

Conditions

Drug Resistant Epilepsy; Unconsciousness

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Liankun Ren

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 16, 2024
• First Posted: August 28, 2024
• Study Start: May 27, 2024
• Primary Completion: December 30, 2024
• Study Completion: March 5, 2025
• Last Updated: July 11, 2025

Record last verified: 2025-07

Locations

CN (1)