Evaluating Modulation Effects of Temporal Interference Using SEEG

Not Applicable

Recruiting

• Conditions: Deep Brain Stimulation; Drug Resistant Epilepsy

• Registration Number: NCT06663969
• Lead Sponsor: Xuanwu Hospital, Beijing

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2024-10-26
• Study First Submitted QC: 2024-10-26
• Study First Posted: 2024-10-29
• Study Start: 2024-11-04
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-03
• Last Update Posted: 2025-02-05
• Primary Completion: 2025-09
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Electrophysiological changes	During the trial(up to 3 hours for each subject)	Electrophysiological waveform changes recorded by stereoelectroencephalography (SEEG) before, during, and after TI stimulation.

Secondary Outcome Measures

Name	Time	Method
Patient's subjective feelings and symptoms	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.

Trial Locations

Locations (1)

Xuanwu Hospital,Capital Medical University; 🇨🇳 Beijing, Beijing, China