Evaluating Modulation Effects of Temporal Interference Using SEEG

NCT ID: NCT06663969

Last Updated: 2025-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-04

Study Completion Date

2025-10-31

Brief Summary

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This single-center prospective study aims to investigate the electrophysiological mechanisms of temporal interference (TI) in humans by analyzing clinical, imaging, and electrophysiological data from patients aged 14-60 with drug-resistant epilepsy.

Detailed Description

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Temporal Interference (TI) technology is a novel non-invasive method for deep brain stimulation (DBS). By generating an overlapping electric field from safe currents, TI creates focused stimulation in targeted deep brain areas. This approach allows for the exploration of deep brain nuclei functions and has the potential to serve as a non-invasive alternative to traditional invasive DBS for clinical treatments.

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.

This study aims to investigate the electrophysiological mechanisms of temporal interference (TI) deep brain stimulation by including patients aged 14-60 with implanted intracranial electrodes. During and after TI stimulation, electrophysiological and clinical data will be recorded. Clinical, imaging, and electrophysiological data will be analyzed and processed to advance understanding of TI's effects in deep brain stimulation.

Conditions

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Deep Brain Stimulation Drug Resistant Epilepsy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Temporal Interference

The investigators performed temporal interference (TI) stimulation to patients with drug-resistant epilepsy undergoing SEEG monitoring. They observed electrophysiological activity and clinical manifestations before, during, and after stimulation to investigate the electrophysiological mechanisms of TI.

Group Type EXPERIMENTAL

Temporal Interference

Intervention Type OTHER

Researchers applied temporal interference (TI) stimulation to the deep brain nuclei of patients who had undergone SEEG monitoring, recording changes in electrical activity detected by SEEG.

Interventions

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Temporal Interference

Researchers applied temporal interference (TI) stimulation to the deep brain nuclei of patients who had undergone SEEG monitoring, recording changes in electrical activity detected by SEEG.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of drug-resistant epilepsy;
* No severe systemic diseases;
* Implantation of stereotactic electrodes;
* Agreement to participate in this study and signs the informed consent form.

Exclusion Criteria

* Hematoma at the scalp electrode site or fluid accumulation under the electrode after intracranial electrode placement.
Minimum Eligible Age

14 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xuanwu Hospital, Beijing

OTHER

Sponsor Role lead

Responsible Party

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Liankun_Ren

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Liankun Ren, MD

Role: PRINCIPAL_INVESTIGATOR

Xuanwu Hospital, Beijing

Locations

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Xuanwu Hospital,Capital Medical University

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Liankun Ren, MD

Role: CONTACT

+86 13681576621

Ren, MD

Role: CONTACT

+86 13681576621

Facility Contacts

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Liankun Ren, MD

Role: primary

+86 13681576621

Other Identifiers

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2024-258-002

Identifier Type: -

Identifier Source: org_study_id

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