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SEEG Guided RF-TC v.s. ATL for mTLE With HS (STARTS)
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Epilepsy, Temporal Lobe | Procedure: SEEG guided RF-TC Procedure: Anterior temporal lobectomy | Not Applicable |
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 (Clinical Trial) |
| Estimated Enrollment : | 60 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Stereotactic-EEG Guided Radio-frequency Thermocoagulation Versus Anterior Temporal Lobectomy for Mesial Temporal Lobe Epilepsy With Hippocampus Sclerosis |
| Actual Study Start Date : | July 14, 2019 |
| Estimated Primary Completion Date : | July 1, 2021 |
| Estimated Study Completion Date : | December 31, 2021 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Anterior temporal lobectomy
surgical treatment for mTLE
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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
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Active Comparator: SEEG guided RF-TC
SEEG recording and minimal invasive treatment for mTLE
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Procedure: SEEG guided RF-TC
SEEG implantation after evaluation, record the interictal and ictal EEG, and perform RF-TC after the localization confirmation.
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- Cognitive function [ Time Frame: 1 year ]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.
- Seizure freedom [ Time Frame: 1 year ]Engel classification at 1 year
- Visual field [ Time Frame: 1 year ]Visual field examination
- Number of participants with procedure related complications [ Time Frame: 1 year ]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 [ Time Frame: 1 year ]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 [ Time Frame: 1 month after surgery ]Whole expenses of each group of patients
| Ages Eligible for Study: | 14 Years to 65 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
| Contact: Sichang Chen, Doctor | +8613581773235 | sierra.csc@hotmail.com | |
| Contact: Penghu Wei, Doctor |
| China | |
| Xuanwu Hospital, Capital Medical University. | Recruiting |
| Beijing, China, 100053 | |
| Contact: Sichang Chen, M.D. +86-13581773235 | |
| Study Director: | Guoguang Zhao, Doctor | Xuanwu hospital, CCMU |
| Tracking Information | |||||||||||||||||
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| First Submitted Date ICMJE | April 23, 2019 | ||||||||||||||||
| First Posted Date ICMJE | May 8, 2019 | ||||||||||||||||
| Last Update Posted Date | August 7, 2019 | ||||||||||||||||
| Actual Study Start Date ICMJE | July 14, 2019 | ||||||||||||||||
| Estimated Primary Completion Date | July 1, 2021 (Final data collection date for primary outcome measure) | ||||||||||||||||
| Current Primary Outcome Measures ICMJE |
Cognitive function [ Time Frame: 1 year ] 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.
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| Original Primary Outcome Measures ICMJE |
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| Change History | |||||||||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||
| Descriptive Information | |||||||||||||||||
| Brief Title ICMJE | SEEG Guided RF-TC v.s. ATL for mTLE With HS | ||||||||||||||||
| Official Title ICMJE | Stereotactic-EEG Guided Radio-frequency Thermocoagulation Versus Anterior Temporal Lobectomy for Mesial Temporal Lobe Epilepsy With Hippocampus Sclerosis | ||||||||||||||||
| 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. |
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| Study Type ICMJE | Interventional | ||||||||||||||||
| Study Phase ICMJE | Not Applicable | ||||||||||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Epilepsy, Temporal Lobe | ||||||||||||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||||||||||
| Estimated Enrollment ICMJE |
60 | ||||||||||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||||||||||
| Estimated Study Completion Date ICMJE | December 31, 2021 | ||||||||||||||||
| Estimated Primary Completion Date | July 1, 2021 (Final data collection date for primary outcome measure) | ||||||||||||||||
| Eligibility Criteria ICMJE |
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 |
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| Sex/Gender ICMJE |
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| Ages ICMJE | 14 Years to 65 Years (Child, Adult, Older Adult) | ||||||||||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | China | ||||||||||||||||
| Removed Location Countries | |||||||||||||||||
| Administrative Information | |||||||||||||||||
| NCT Number ICMJE | NCT03941613 | ||||||||||||||||
| Other Study ID Numbers ICMJE | 2018011021001 | ||||||||||||||||
| Has Data Monitoring Committee | Yes | ||||||||||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Xuanwu Hospital, Beijing | ||||||||||||||||
| Study Sponsor ICMJE | Xuanwu Hospital, Beijing | ||||||||||||||||
| Collaborators ICMJE | Not Provided | ||||||||||||||||
| Investigators ICMJE |
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| PRS Account | Xuanwu Hospital, Beijing | ||||||||||||||||
| Verification Date | November 2018 | ||||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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