Temporal Interference for Temporal Lobe Epilepsy Under SEEG

Not Applicable

Not yet recruiting

• Conditions: Epilepsy

• Registration Number: NCT07082101
• Lead Sponsor: Xijing Hospital

Brief Summary

This study evaluates the effect of temporal interference (TI) stimulation on biomarkers in patients with temporal lobe epilepsy (TLE) under stereo-electroencephalography (SEEG), and provides theoretical basis for non-invasive TI treatment of temporal lobe epilepsy.

Detailed Description

10 patients aged 18-65 years with TLE assessed by semiology, video electroencephalogram and imaging in Epilepsy Center of Xijing Hospital (Xi'an, China) will be recruited. Clinical baseline data such as general information and history of seizures will be collected. The SEEG electrodes were implanted in the Department of neurosurgery of Xijing Hospital and after 24 hours TI will be performed with continuous SEEG monitoring. Finally, the biomarker changes of EEG signals before and after TI treatment were statistically analyzed.

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-29
• Study First Submitted QC: 2025-07-22
• Last Update Submitted: 2025-07-22
• Study First Posted: 2025-07-24
• Last Update Posted: 2025-07-24
• Study Start: 2025-08-15
• Primary Completion: 2026-07
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Clinical diagnosis of drug refractory epilepsy and temporal lobe epilepsy;
• Patients undergoing SEEG;
• Able to cooperate the treatment and related inspection;
• Fully understands and signs informed consent.

Exclusion Criteria

• Patients with temporal plus epilepsy;
• In status epilepticus;
• With other severe disease;
• Pregnancy or lactation women;
• Unable to tolerate SEEG or TI;
• At the same time to participate in other clinical trials;
• Withdraw consent procedure.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of interictal electrophysiological biomaker changes in epilepsy	24 hours after TI stimulation	Electrophysiological biomarkers changes recorded by SEEG through the experiment.

Trial Locations

Locations (1)

Xijing Hospital; 🇨🇳 Xi'an, Shaanxi, China