Evaluating Modulation Effects of Temporal Interference Using SEEG

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06663969

Enrollment

Registered

2024-10-29

Start date

2024-11-04

Completion date

2025-10-31

Last updated

2025-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deep Brain Stimulation, Drug Resistant Epilepsy

Keywords

Temporal Interference, Stereoelectroencephalography, Drug Resistant Epilepsy

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.

Interventions

OTHERTemporal 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

14 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

China

Contacts

Primary ContactLiankun Ren, MD

renlk2022@outlook.com+86 13681576621

Backup ContactRen, MD