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

  • Clinicaltrials.gov identifier

    NCT03941613

  • Recruitment Status

    Recruiting

  • First Posted

    May 8, 2019

  • Last update posted

    August 7, 2019

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.

  • Condition or Disease:Epilepsy, Temporal Lobe
  • Intervention/Treatment: Procedure: SEEG guided RF-TC
    Procedure: Anterior temporal lobectomy
  • Phase: N/A

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

  • Study Type: Interventional
  • 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 2019
  • Estimated Primary Completion Date: July 2021
  • Estimated Study Completion Date: December 2021

Arms and interventions

Arm Intervention/treatment
Active Comparator: SEEG guided RF-TC
SEEG recording and minimal invasive treatment for mTLE
Procedure: SEEG guided RF-TC
SEEG implantation after evaluation, record the interictal and ictal EEG, and perform RF-TC after the localization confirmation.
Experimental: Anterior temporal lobectomy
surgical treatment for mTLE
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

Outcome Measures

  • Primary Outcome Measures: 1. 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.
  • Secondary Outcome Measures: 1. Seizure freedom [ Time Frame: 1 year ]
    Engel classification at 1 year
  • 2. Visual field [ Time Frame: 1 year ]
    Visual field examination
  • 3. 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.
  • 4. 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)
  • 5. Average hospitalization expenses [ Time Frame: 1 month after surgery ]
    Whole expenses of each group of patients

Eligibility Criteria

  • Ages Eligible for Study: 14 to 65 Years (Child, Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Sichang Chen, Doctor +8613581773235 sierra.csc@hotmail.com

Contact: Penghu Wei, Doctor

Locations

China
Xuanwu Hospital, Capital Medical University.
Beijing

Sponsors and Collaborators

Xuanwu Hospital, Beijing

Investigators

Study Director: Guoguang Zhao, Doctor Xuanwu hospital, CCMU

More Information

  • Responsible Party: Xuanwu Hospital, Beijing
  • ClinicalTrials.gov Identifier: NCT03941613 History of Changes
  • Other Study ID Numbers: 2018011021001
  • First Posted: May 8, 2019 Key Record Dates
  • Last Update Posted: August 7, 2019
  • Last Verified: November 2018
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: Yes
  • Plan Description: The baseline information and follow-up data are available to other researchers.
  • Supporting Materials: Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report (CSR)
  • Time Frame: Within 1 year after the last follow-up.
  • Access Criteria: PI of any of Epilepsy center
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Product Manufactured in and Exported from the U.S.: Yes
  • Keywords provided by Xuanwu Hospital, Beijing: temporal lobe epilepsy; hippocampus sclerosis (HS); radiofrequency thermocoagulation (RF-TC); cognitive status
  • Additional relevant MeSH terms: Epilepsy Epilepsy, Temporal Lobe