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

NCT03941613 | Completed DMC

• 1 other identifier: 2018011021001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Epilepsy, Temporal Lobe

Keywords

temporal lobe epilepsy; hippocampus sclerosis (HS); radiofrequency thermocoagulation (RF-TC); cognitive status

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Seizure freedom

  1 year

• Visual field

  1 year

• Number of participants with procedure related complications

  1 year

• Quality of life after treatment

  1 year

• Average hospitalization expenses

  1 month after surgery

Study Arms (2)

Anterior temporal lobectomy

EXPERIMENTAL

surgical treatment for mTLE

Procedure: Anterior temporal lobectomy

SEEG guided RF-TC

ACTIVE COMPARATOR

SEEG recording and minimal invasive treatment for mTLE

Procedure: SEEG guided RF-TC

Interventions

SEEG guided RF-TC PROCEDURE

SEEG implantation after evaluation, record the interictal and ictal EEG, and perform RF-TC after the localization confirmation.

SEEG guided RF-TC

Anterior temporal lobectomy PROCEDURE

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

Anterior temporal lobectomy

Eligibility Criteria

• Age: 14 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University.

Beijing, 100053, China

Location

Related Publications (2)

• Shan Y, Shi J, Wang T, Chen S, Feng T, Yin L, Ren L, Wei P, Yang Y, Wang H, Zhao G. Optimized stereoelectroencephalography-guided thermocoagulation versus anterior temporal lobectomy in mesial temporal epilepsy: A pilot randomized controlled study. J Adv Res. 2025 Jun 19:S2090-1232(25)00451-5. doi: 10.1016/j.jare.2025.06.042. Online ahead of print.

  PMID: 40543839 DERIVED

• 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.

  PMID: 34187524 DERIVED

MeSH Terms

Conditions

Epilepsy, Temporal Lobe

Interventions

Anterior Temporal Lobectomy

Condition Hierarchy (Ancestors)

Epilepsies, Partial; Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epileptic Syndromes

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Neurosurgical Procedures

Study Officials

• Guoguang Zhao, Doctor

  Xuanwu hospital, CCMU

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2019
• First Posted: May 8, 2019
• Study Start: August 5, 2019
• Primary Completion: December 19, 2021
• Study Completion: January 5, 2023
• Last Updated: March 24, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Within 1 year after the last follow-up.
• Access Criteria: PI of any of Epilepsy center

Locations

CN (1)