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

Primary Purpose

Epilepsy, Temporal Lobe

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

SEEG guided RF-TC

Anterior temporal lobectomy

About this trial

This is an interventional treatment trial for Epilepsy, Temporal Lobe focused on measuring temporal lobe epilepsy; hippocampus sclerosis (HS); radiofrequency thermocoagulation (RF-TC); cognitive status

Eligibility Criteria

14 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Xuanwu Hospital, Capital Medical University.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Anterior temporal lobectomy

SEEG guided RF-TC

Arm Description

surgical treatment for mTLE

SEEG recording and minimal invasive treatment for mTLE

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Seizure freedom

Engel classification at 1 year

Visual field

Visual field examination

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.

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)

Average hospitalization expenses

Whole expenses of each group of patients

Full Information

NCT ID

NCT03941613

First Posted

April 23, 2019

Last Updated

March 22, 2023

Sponsor

Xuanwu Hospital, Beijing

1. Study Identification

Unique Protocol Identification Number

NCT03941613

Brief Title

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

Acronym

STARTS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

August 5, 2019 (Actual)

Primary Completion Date

December 19, 2021 (Actual)

Study Completion Date

January 5, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Xuanwu Hospital, Beijing

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Epilepsy, Temporal Lobe

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Anterior temporal lobectomy

Arm Type

Experimental

Arm Description

surgical treatment for mTLE

Arm Title

SEEG guided RF-TC

Arm Type

Active Comparator

Arm Description

SEEG recording and minimal invasive treatment for mTLE

Intervention Type

Procedure

Intervention Name(s)

SEEG guided RF-TC

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Anterior temporal lobectomy

Intervention Description

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

Primary Outcome Measure Information:

Title

Cognitive function

Description

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.

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Seizure freedom

Description

Engel classification at 1 year

Time Frame

1 year

Title

Visual field

Description

Visual field examination

Time Frame

1 year

Title

Number of participants with procedure related complications

Description

Time Frame

1 year

Title

Quality of life after treatment

Description

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)

Time Frame

1 year

Title

Average hospitalization expenses

Description

Whole expenses of each group of patients

Time Frame

1 month after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Guoguang Zhao, Doctor

Organizational Affiliation

Xuanwu hospital, CCMU

Official's Role

Study Director

Facility Information:

Facility Name

Xuanwu Hospital, Capital Medical University.

City

Beijing

ZIP/Postal Code

100053

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

Citations:

PubMed Identifier

34187524

Citation

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.

Results Reference

derived

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

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