Epilepsy, Temporal LobeSTARTSNCT03941613
SEEG Guided RF-TC v.s. ATL for mTLE With HS
A study testing SEEG guided RF-TC and Anterior temporal lobectomy in people with Epilepsy, Temporal Lobe, run by Xuanwu Hospital, Beijing at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 14 to 65 years
- Conditions the study is for
- Epilepsy, Temporal Lobe
- What is being tested?
- SEEG guided RF-TC and Anterior temporal lobectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 5 Aug 2019to 5 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Epilepsy, Temporal Lobe
- Being tested
- SEEG guided RF-TC, Anterior temporal lobectomy
- Keywords
- temporal lobe epilepsy; hippocampus sclerosis (HS); radiofrequency thermocoagulation (RF-TC); cognitive status
- Medical subject headings
- Epilepsy, Temporal Lobe
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SEEG guided RF-TCProcedure or surgery
SEEG implantation after evaluation, record the interictal and ictal EEG, and perform RF-TC after the localization confirmation.
Anterior temporal lobectomyProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Anterior temporal lobectomy | Experimental | surgical treatment for mTLE Receives: Procedure: Anterior temporal lobectomy |
| SEEG guided RF-TC | Active comparator | SEEG recording and minimal invasive treatment for mTLE Receives: Procedure: SEEG guided RF-TC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (5)
Seizure freedom
Engel classification at 1 year
Measured: 1 year
Visual field
Visual field examination
Measured: 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.
Measured: 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)
Measured: 1 year
Average hospitalization expenses
Whole expenses of each group of patients
Measured: 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2019
- Study start5 Aug 2019
- Primary completion19 Dec 2021
- Study completion5 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Epilepsy, Temporal LobeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guoguang Zhao, Doctor, Study director, Xuanwu hospital, CCMU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03941613
- Sponsor's protocol ID
- 2018011021001
- Acronym
- STARTS
- Status last verified
- Mar 2023
- First submitted
- 23 Apr 2019
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The baseline information and follow-up data are available to other researchers.
Publications
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. 2026 Mar;81:955-965. doi: 10.1016/j.jare.2025.06.042. Epub 2025 Jun 19.
PubMed 40543839Wang 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.
PubMed 34187524
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic-EEG Guided Radio-frequency Thermocoagulation Versus Anterior Temporal Lobectomy for Mesial Temporal Lobe Epilepsy With Hippocampus Sclerosis
- ClinicalTrials.gov ID
- NCT03941613
- Acronym / sponsor ID
- STARTS / 2018011021001
- Conditions
- Epilepsy, Temporal Lobe
- Keywords
- temporal lobe epilepsy; hippocampus sclerosis (HS); radiofrequency thermocoagulation (RF-TC); cognitive status
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 5 Aug 2019 (actual)
- Primary completion
- 19 Dec 2021 (actual)
- Study completion
- 5 Jan 2023 (actual)
- First posted
- 8 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anterior temporal lobectomy | Experimental | Procedure: Anterior temporal lobectomysurgical treatment for mTLE |
| SEEG guided RF-TC | Active comparator | Procedure: SEEG guided RF-TCSEEG recording and minimal invasive treatment for mTLE |
Who may qualify
- Ages
- 14 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SEEG guided RF-TCSEEG implantation after evaluation, record the interictal and ictal EEG, and perform RF-TC after the localization confirmation. | Procedure or surgery | SEEG guided RF-TC |
| Anterior temporal lobectomyclassical 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 | Procedure or surgery | Anterior temporal lobectomy |
Primary outcome
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.
5 secondary outcomes
Seizure freedom
Time frame: 1 year
Visual field
Time frame: 1 year
Number of participants with procedure related complications
Time frame: 1 year
Quality of life after treatment
Time frame: 1 year
Average hospitalization expenses
Time frame: 1 month after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Derived from this study: PubMed 40543839Shan 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. 2026 Mar;81:955-965. doi: 10.1016/j.jare.2025.06.042. Epub 2025 Jun 19.
- Derived from this study: PubMed 34187524Wang 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.
- Individual participant dataSharing planned: Yes. The baseline information and follow-up data are available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guoguang Zhao, Doctor study director
Xuanwu hospital, CCMU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SEEG guided RF-TC and Anterior temporal lobectomy in people with Epilepsy, Temporal Lobe, run by Xuanwu Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive function (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03941613, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2023.