Efficacy of 128-channel EEG Combined With BESA Dipole Localization and Intervention on Brain Waves for Epilepsy

Efficacy of 128-channel Electroencephalograph Combined With BESA Dipole Localization Method and Intervention on Brain Waves for Epilepsy

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.

Study Overview

• Status: Completed
• Conditions: Epilepsy
• Intervention / Treatment: Device: cathode tDCS; Device: Sham cathode tDCS

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.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Department of Neurology, Zhongshan Hospital, Fudan University, Shanghai, China

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosed with epilepsy at least 1 year according to the 2010 International League Against Epilepsy (ILAE) criteria.
• Aged 18 to 65 years old.
• The seizure is not well-controlled by antiepileptic drugs, the patient cannot tolerant the side effect of antiepileptic drugs, or the patient is not satisfied with the curative effect.
• The dose of antiepileptic drugs must be stable in the last 4 weeks.
• The patient or his/her family member is able to recording the frequency of seizures and complete the trial.

Exclusion Criteria:

• History of status epilepticus in the last 12 weeks according to the definition by Neurocritical Care Society (NCS) 2012.
• History of transcranial direct current stimulation, repetitive transcranial magnetic stimulation, vagus nerve stimulation, trigeminal nerve stimulation or deep brain stimulation. History of pacemaker or other metal equipment implantation.
• History of skull defect, brain tumor, encephalitis, progressive encephalopathy and other progressive diseases of central nervous system.
• History of severe cardiac, hepatic, renal, hematologic diseases, or other progressive and systemic diseases, or during pregnancy.
• History of major depression and other mental disturbance, color blindness, hearing or language disorder who is not able to complete the trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; Active Intervention on brain waves by cathode tDCS	Device: cathode tDCS; 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).
Sham Comparator: Control Group; Sham Intervention on brain waves by cathode tDCS	Device: Sham cathode tDCS; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seizure frequency	The frequency of seizures using diary	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MMSE	The cognitive function using Mini-mental state examination	6 months
MoCA	The cognitive function using Montreal cognitive assessment	6 months
AVLT	The cognitive function using auditory verbal learning test (	6 months
SDMT	The cognitive function using symbol digit modalities test	6 months
CWT	The cognitive function using Stroop color word test	6 months
EPQ	The psychology evaluation using Eysenck personality questionnaire	6 months
HAMD-17	The psychology evaluation using Hamilton rating scale for depression-17	6 months
SCL-90	The psychology evaluation using symptom check list-90	6 months
QOLIE-31	The life quality using quality of life in epilepsy-31	6 months
Epileptiform discharges	The number of epileptiform discharges using 30min EEG	6 months
fMRI analysis	Graph theory-based fMRI analysis	6 months

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Investigators: Principal Investigator: Xin Wang, MD, Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): March 1, 2019
• Study Completion (Actual): May 1, 2019

Study Registration Dates

• First Submitted: November 15, 2015
• First Submitted That Met QC Criteria: November 20, 2015
• First Posted (Estimate): November 24, 2015

Study Record Updates

• Last Update Posted (Actual): February 25, 2020
• Last Update Submitted That Met QC Criteria: February 21, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Epilepsy; Transcranial Direct Current Stimulation; 128-Channel EEG; Dipole Localization
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: 128EEG