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NCT Number: NCT06575413

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.

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Key information

Conditions

Refractory Epilepsy Brain Diseases Central Nervous System Diseases Consciousness Disorders Consciousness, Loss of Drug Resistant Epilepsy Epilepsy Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Unconsciousness

Age range

14 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xuanwu Hospital,Capital Medical University

Beijing, Beijing Municipality, 100053, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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)

  3. 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.

Sponsors and collaborators

Lead sponsor

Xuanwu Hospital, Beijing

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Aug 28, 2024
Registry last updated
Jul 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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