NCT06558864

High Selective Subiculum SEEG Guided RF-TC for mTLE-HS

The Efficacy and Safety of Subiculum Stereotactic-EEG Guided Radio-frequency Thermocoagulation for Mesial Temporal Lobe Epilepsy With Hippocampus Sclerosis: A Prospective, Single-Arm Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Xuanwu Hospital, Beijing · Academic / Other
• Sex: All
• Age: 14 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this research is to study the efficacy and safety of Stereotactic EEG (SEEG) guided radio-frequency thermocoagulation (RF-TC) of Subiculum as adjunctive therapy for reducing the frequency of seizures in drug-resistant temporal lobe epilepsy with Mesial temporal lobe epilepsy with hippocampal sclerosis (mTLE-HS).

Detailed description

Mesial temporal lobe epilepsy (mTLE) is the most classical subtype of temporal lobe epilepsy, which is the indication of surgical intervention after evaluation. This project aims to include 20 participants, and evaluate the effectiveness and safety of Stereotactic EEG (SEEG) guided radio-frequency thermocoagulation (RF-TC) of Subiculum in patients with mesial temporal lobe epilepsy with hippocampal sclerosis through A prospective, interventional, unblinded, single-arm clinical trial. It is expected to provide new therapeutic options for patients with mTLE-HS with alternative treatment options.

Conditions

• Mesial Temporal Lobe Epilepsy With Hippocampal Sclerosis
• Epilepsy

Interventions

Type	Name	Description
PROCEDURE	Subiculum RF-TC	SEEG implantation after evaluation, record the interictal and ictal EEG, and perform Subiculum RF-TC.

Timeline

• Start date: 2024-08-09
• Primary completion: 2025-08-20
• Completion: 2027-08-20
• First posted: 2024-08-19
• Last updated: 2024-08-19