Refractory EpilepsyNCT06575413
Investigating the Role and Electrophysiological Characteristics of the Human Claustrum Based on SEEG
A study testing Direct Electrical Stimulation in people with Refractory Epilepsy and Consciousness, Loss of, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 65 years
- Conditions the study is for
- Refractory Epilepsy, Consciousness, Loss of
- What is being tested?
- Direct Electrical Stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteChina
- Study dates
- 27 May 2024to 5 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 1. Subjects that experience surgical complications during the implant procedure will be excluded from the study
Trial locations and contacts
1 site in 1 country.
China1 site
Xuanwu Hospital,Capital Medical University
Beijing, Beijing Municipality, 100053
About this study
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.
Read the 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.
- Conditions
- Refractory Epilepsy, Consciousness, Loss of
- Being tested
- Direct Electrical Stimulation
- Keywords
- Refractory Epilepsy, Consciousness, Claustrum
- Medical subject headings
- Drug Resistant Epilepsy, Unconsciousness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct Electrical StimulationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Direct Electrical Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients Clinical responses Rating
Researchers categorized patients' clinical responses as normal, mild, moderate, or severe based on their subjective clinical response.
Measured: 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)
Measured: 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.
Measured: During the trial(up to 3 hours for each subject)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start27 May 2024
- Primary completion30 Dec 2024
- Study completion5 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Refractory EpilepsyStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liankun_Ren, Xuanwu Hospital, Beijing
- Investigators
- Liankun Ren, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06575413
- Sponsor's protocol ID
- 2024-125-001
- Status last verified
- Jul 2025
- First submitted
- 16 Aug 2024
- Last updated
- 11 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cheng Y, Zheng Y, Wang W, Ai H, Wang X, Xu C, Wang X, Hu D, Wang Z, Lu R, Huang Z, Hou Y, Chen W, Ren L. Disruption of the claustrum-ACC pathway contributes to human mind blanking. Neurobiol Dis. 2026 Sep;227:107520. doi: 10.1016/j.nbd.2026.107520. Epub 2026 Jul 4.
PubMed 42401244
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Role and Electrophysiological Characteristics of the Human Claustrum Based on SEEG
- ClinicalTrials.gov ID
- NCT06575413
- Acronym / sponsor ID
- 2024-125-001
- Conditions
- Refractory Epilepsy, Consciousness, Loss of
- Keywords
- Refractory Epilepsy, Consciousness, Claustrum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 27 May 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 5 Mar 2025 (actual)
- First posted
- 28 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Direct electrical stimulation of the Claustrum | Experimental | Other: Direct Electrical StimulationThe 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. |
Who may qualify
- Ages
- 14 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- 1. Subjects that experience surgical complications during the implant procedure will be excluded from the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Direct Electrical StimulationThe 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. | Other | Direct electrical stimulation of the Claustrum |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Derived from this study: PubMed 42401244Cheng Y, Zheng Y, Wang W, Ai H, Wang X, Xu C, Wang X, Hu D, Wang Z, Lu R, Huang Z, Hou Y, Chen W, Ren L. Disruption of the claustrum-ACC pathway contributes to human mind blanking. Neurobiol Dis. 2026 Sep;227:107520. doi: 10.1016/j.nbd.2026.107520. Epub 2026 Jul 4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liankun Ren principal investigator
Xuanwu Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Direct Electrical Stimulation in people with Refractory Epilepsy and Consciousness, Loss of, run by Xuanwu Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients Clinical responses Rating (time frame: During the trial(up to 3 hours for each subject)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06575413, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.