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
| Type | Name | Description |
|---|---|---|
| PROCEDURE | SEEG guided RF-TC | SEEG implantation after evaluation, record the interictal and ictal EEG, and perform RF-TC after the localization confirmation. |
| PROCEDURE | Anterior temporal lobectomy | classical 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.