Evaluating Modulation Effects of Temporal Interference Using SEEG

Capital Medical University

Status: Enrolling

Conditions: Drug Resistant Epilepsy; Deep Brain Stimulation

Treatments: Other: Temporal Interference

Study type: Interventional

Funder types: Other

Identifiers

NCT06663969

2024-258-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 14 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Temporal Interference

Experimental group

Description:

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.

Treatment:

Other: Temporal Interference