Efficacy of 128-channel EEG Combined With BESA Dipole Localization and Intervention on Brain Waves for Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional

Summary: 
      The prevalence of epilepsy is about 0.5% to 1% worldwide, with high disability and mortality
      rate. The 128-channel electroencephalograph (EEG), combined with BESA dipole localization
      method, is able to provide more specific information about the brain activity and find out
      the epileptogenic focus. Based on this novel EEG recording method, cathode transcranial
      direct current stimulation (tDCS) targeting the epileptogenic focus can be used to decrease
      the excitability of the cortex, thus reducing the frequency of seizures. A single-center
      double-blinded randomized controlled and open-label extension trial will be carried out to
      study the efficacy of 128-channel electroencephalograph combined with BESA dipole
      localization method and Intervention on brain waves for epilepsy.
    

Detailed description: 
      Background: The prevalence of epilepsy is about 0.5% to 1% worldwide, with high disability
      and mortality rate. The 128-channel electroencephalograph (EEG), combined with Brain
      Electrical Source Analysis (BESA) dipole localization method, is able to provide more
      specific information about the brain activity and find out the epileptogenic focus. Based on
      this novel EEG recording method, cathode transcranial direct current stimulation (tDCS)
      targeting the epileptogenic focus can be used to decrease the excitability of the cortex,
      thus reducing the frequency of seizures.

      Methods: A single-center double-blinded randomized controlled and open-label extension trial
      will be carried out to study the efficacy of 128-channel electroencephalograph combined with
      BESA dipole localization method and Intervention on brain waves for epilepsy. Adult patients
      aged 18 to 65 years old with epilepsy will be recruited. The study contains two stages. At
      the first randomized controlled stage, patients will be randomly assigned to experimental and
      control group with a 1:1 sqrt allocation and undergo five daily sessions of brain-wave
      intervention by cathode tDCS （20min, 1mA） targeting the epileptogenic focus, which is
      confirmed by 128-channel EEG and BESA dipole localization method. Active intervention will be
      carried out for the experimental group, and sham intervention ( the stimulator will be turned
      off after 5s) for the control group. The frequency of seizures, the number of epileptiform
      discharges, the diffusion tensor imaging (DTI) of magnetic resonance imaging (MRI), the
      cognitive function, the psychology and the life quality will be measured before (baseline), 1
      hour, 4 weeks and 12 weeks after the last intervention to evaluate the changes after
      intervention. At the second open-label extension stage, all the patients will undergo five
      daily sessions of active intervention (20min, 1mA) and be followed up for 12 weeks similar to
      the first stage.
    

Intervention name(s): cathode tDCS; Sham cathode tDCS
Intervention type(s): Device; Device
Intervention description(s): At the first randomized controlled stage, the experimental group will undergo five daily sessions of active brain-wave intervention by cathode tDCS (20min, 1mA) targeting the epileptogenic focus, which is confirmed by 128-channel EEG and BESA dipole localization method.
At the second open-label extension stage, all the patients will undergo five daily sessions of active intervention (20min, 1mA).; At the first randomized controlled stage, the control group will undergo five daily sessions of sham brain-wave intervention by cathode tDCS (20min, 1mA, the stimulator will be turned off after 5s) targeting the epileptogenic focus, which is confirmed by 128-channel EEG and BESA dipole localization method.
At the second open-label extension stage, all the patients will undergo five daily sessions of active intervention (20min, 1mA).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Epilepsy; 128-Channel EEG; Dipole Localization; Transcranial Direct Current Stimulation