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

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

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.

Study Overview

• Status: Completed
• Conditions: Epilepsy, Temporal Lobe
• Intervention / Treatment: Procedure: Anterior temporal lobectomy; Procedure: SEEG guided RF-TC

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sichang Chen, Doctor; Phone Number: +8613581773235; Email: sierra.csc@hotmail.com
• Study Contact Backup: Name: Penghu Wei, Doctor

Study Locations

• China
  • Beijing, China, 100053
    • Xuanwu Hospital, Capital Medical University.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Clinical diagnosis of drug resistant epilepsy

At least one or more anti-epileptic drugs (AEDs) regular administered for more than 2 years, one of which was either Dilantin, Tegretol, Carbatrol, or Trileptal used in appropriate doses, have failed due to inefficacy, not intolerance

Persistence of disabling seizures at least 3 times per 3 months or greater, and once or more in recent 1 month

14 years or older at enrollment

Simple and complex partial seizures, with or without secondarily generalized seizures beginning in childhood or later, with or without febrile convulsions earlier

Auras that occur in isolation and are not primary sensory other than olfactory or gustatory

I.Q. of greater than 70

Hippocampal atrophy on MRI T1 imaging with increased ipsilateral mesial signal on T2 imaging

Interictal EEG shows focal or lateralized spikes on temporal, frontal zone, or sphenoid electrode

Ictal EEG onset is focal or lateralized on the ipsilateral side

Ipsilateral temporal focal hypometabolism on PET

Must be agreed by a consensus of ipsilateral mesial temporal origin by a multidisciplinary discussion

Must be able to understand and speak Mandarin

Exclusion criteria:

A history of serious cerebral insult after the age of 5

A progressive neurological disorder; mental retardation (I.Q. less than 70)

Psychogenic seizures

Focal neurological deficits other than memory disturbances

Any unexplained focal or lateralized neurological deficits other than memory dysfunction.

Temporal neocortical or extratemporal lesions on MRI

Psychosis, current or recent substance abuse, suicidality, anorexia, or psychogenic seizures

Severe systemic diseases

Unequivocal focal extratemporal EEG slowing or interictal spikes

Lesions on MRI outside of the mesial temporal area

Diffuse unilateral or bilateral hypometabolism on positron emission tomography (PET)

Contralateral or extratemporal ictal onset

Persistent extratemporal, or predominant contralateral focal interictal spikes or slowing, or generalized interictal spikes

Patient who was included in any clinical trial

Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Anterior temporal lobectomy; surgical treatment for mTLE	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
Active Comparator: SEEG guided RF-TC; SEEG recording and minimal invasive treatment for mTLE	Procedure: SEEG guided RF-TC; SEEG implantation after evaluation, record the interictal and ictal EEG, and perform RF-TC after the localization confirmation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive function	Full scaled Wechsler Adult Intelligence Quality IV Chinese edition (WAIS-IV-C), or Wechsler Children Intelligence Quality IV Chinese edition (WCIS-IV-C) Higher values represent a better outcome.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seizure freedom	Engel classification at 1 year	1 year
Visual field	Visual field examination	1 year
Number of participants with procedure related complications	Postoperative stroke with or without symptoms (by MRI); Postoperative intracranial bleeding with or without symptoms (by MRI); Postoperative intracranial infection; Postoperative wound infection; Postoperative subcutaneous dropsy.	1 year
Quality of life after treatment	Quality of Life in Epilepsy 89 (QOLIE-89) for adults (aged from 17-60), and Quality of Life in Epilepsy 89 (QOLIE-48) for children (aged from 14-16)	1 year
Average hospitalization expenses	Whole expenses of each group of patients	1 month after surgery

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing
• Investigators: Study Director: Guoguang Zhao, Doctor, Xuanwu hospital, CCMU

Publications and helpful links

General Publications

• Wang YH, Chen SC, Wei PH, Yang K, Fan XT, Meng F, Du JL, Ren LK, Shan YZ, Zhao GG. Stereotactic EEG-guided radiofrequency thermocoagulation versus anterior temporal lobectomy for mesial temporal lobe epilepsy with hippocampal sclerosis: study protocol for a randomised controlled trial. Trials. 2021 Jun 29;22(1):425. doi: 10.1186/s13063-021-05378-3.

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2019
• Primary Completion (Actual): December 19, 2021
• Study Completion (Actual): January 5, 2023

Study Registration Dates

• First Submitted: April 23, 2019
• First Submitted That Met QC Criteria: May 6, 2019
• First Posted (Actual): May 8, 2019

Study Record Updates

• Last Update Posted (Actual): March 24, 2023
• Last Update Submitted That Met QC Criteria: March 22, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: temporal lobe epilepsy; hippocampus sclerosis (HS); radiofrequency thermocoagulation (RF-TC); cognitive status
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epileptic Syndromes; Epilepsies, Partial; Epilepsy; Epilepsy, Temporal Lobe
• Other Study ID Numbers: 2018011021001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The baseline information and follow-up data are available to other researchers.
• IPD Sharing Time Frame: Within 1 year after the last follow-up.
• IPD Sharing Access Criteria: PI of any of Epilepsy center
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No