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

Epilepsy, Temporal Lobe Clinical Trial

— STARTS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03941613
• Other study ID #: 2018011021001
• Status: Completed
• Phase: N/A
• Start date: August 5, 2019
• Est. completion date: January 5, 2023

Study information

• Verified date: March 2023
• Source: Xuanwu Hospital, Beijing
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 5, 2023
• Est. primary completion date: December 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy
• Epilepsy, Temporal Lobe

Intervention

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

Locations

Country	Name	City	State
China	Xuanwu Hospital, Capital Medical University.	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Seizure freedom	Engel classification at 1 year	1 year
Secondary	Visual field	Visual field examination	1 year
Secondary	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
Secondary	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
Secondary	Average hospitalization expenses	Whole expenses of each group of patients	1 month after surgery