Clinical Trials Directory

Trials / Completed

CompletedNCT03941613

SEEG Guided RF-TC v.s. ATL for mTLE With HS

Stereotactic-EEG Guided Radio-frequency Thermocoagulation Versus Anterior Temporal Lobectomy for Mesial Temporal Lobe Epilepsy With Hippocampus Sclerosis

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
40 (actual)
Sponsor
Xuanwu Hospital, Beijing · Academic / Other
Sex
All
Age
14 Years – 65 Years
Healthy volunteers
Not accepted

Summary

Mesial temporal lobe epilepsy (mTLE) is the most classical subtype of temporal lobe epilepsy, which is the indication of surgical intervention after evaluation. Until now, anterior temporal lobectomy (ATL) is still the recommended treatment for mTLE. However, evidences are accumulated including post ATL tetartanopia and memory deterioration and new minimized invasive treatments are introduced. Stereotactic EEG (SEEG) guided radio-frequency thermocoagulation (RF-TC) is one of the option with lower seizure freedom but with higher neurological function reservation. This study is aiming at comparison of the efficacy and safety between SEEG guided RF-TC and classical ATL in the treatment of mTLE.

Detailed description

Nowadays, more and more patients received SEEG implantation for the evaluation of intractable seizures. SEEG is not only a diagnostic method to locate the origin of the epileptic seizures but also a media to treat or to cure this disease. Using radiofrequency thermocoagulation, we are able to coagulate some part of the brain guided by SEEG. However, until now, we don't have high level evidence for the efficacy and safety of RF-TC. In our resent series, we found the 1 year seizure free rate of mTLE patients after RF-TC is about 80% without any notable complication. In this trail, we will compare the efficacy as well as the safety of anterior temporal lobectomy with RF-TC for the mTLE patients, including the 1 year Engel class, perioperative complications, cognitive function, visual field, etc. Thus we can provide more high level evidence on the usage of SEEG guided RF-TC on mTLE patients.

Conditions

Interventions

TypeNameDescription
PROCEDURESEEG guided RF-TCSEEG implantation after evaluation, record the interictal and ictal EEG, and perform RF-TC after the localization confirmation.
PROCEDUREAnterior temporal lobectomyclassical surgical treatment for mesial temporal lobe epilepsy, including the resection of neocortex for 5.5cm in non dominant hemisphere or 4.5cm in dominant hemisphere

Timeline

Start date
2019-08-05
Primary completion
2021-12-19
Completion
2023-01-05
First posted
2019-05-08
Last updated
2023-03-24

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT03941613. Inclusion in this directory is not an endorsement.