Skip to main content
Clinical Trials/NCT06663969
NCT06663969
Recruiting
Not Applicable

Evaluating Modulation Effects of Temporal Interference Using SEEG

Xuanwu Hospital, Beijing1 site in 1 country20 target enrollmentNovember 4, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Deep Brain Stimulation
Sponsor
Xuanwu Hospital, Beijing
Enrollment
20
Locations
1
Primary Endpoint
Electrophysiological changes
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 4, 2024
End Date
October 2025
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Liankun_Ren

Professor

Xuanwu Hospital, Beijing

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Electrophysiological changes

Time Frame: During the trial(up to 3 hours for each subject)

Electrophysiological waveform changes recorded by stereoelectroencephalography (SEEG) before, during, and after TI stimulation.

Secondary Outcomes

  • Patient's subjective feelings and symptoms(During the trial(up to 3 hours for each subject))

Study Sites (1)

Loading locations...

Similar Trials