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

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ClinicalTrials.gov Identifier: NCT02613234
Recruitment Status : Recruiting
First Posted : November 24, 2015
Last Update Posted : March 24, 2016
Sponsor:
Information provided by (Responsible Party):
Weifeng Peng, Shanghai Zhongshan Hospital

Brief 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 single-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.

Condition or disease Intervention/treatment Phase
Epilepsy Device: cathode tDCS Device: Sham cathode tDCS Not Applicable

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 single-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  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Efficacy of 128-channel Electroencephalograph Combined With BESA Dipole Localization Method and Intervention on Brain Waves for Epilepsy: A Single-blinded Randomized Controlled and Open-label Extension Trial
Study Start Date : November 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

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).





Primary Outcome Measures :
  1. The frequency of seizures using diary [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. The cognitive function using Mini-mental state examination (MMSE) [ Time Frame: 6 months ]
  2. The cognitive function using Montreal cognitive assessment (MoCA) [ Time Frame: 6 months ]
  3. The cognitive function using auditory verbal learning test (AVLT) [ Time Frame: 6 months ]
  4. The cognitive function using symbol digit modalities test (SDMT) [ Time Frame: 6 months ]
  5. The cognitive function using Stroop color word test (CWT) [ Time Frame: 6 months ]
  6. The psychology evaluation using Eysenck personality questionnaire (EPQ) [ Time Frame: 6 months ]
  7. The psychology evaluation using Hamilton rating scale for depression-17 (HAMD-17) [ Time Frame: 6 months ]
  8. The psychology evaluation using symptom check list-90 (SCL-90) [ Time Frame: 6 months ]
  9. The life quality using quality of life in epilepsy-31 (QOLIE-31) [ Time Frame: 6 months ]
  10. The number of epileptiform discharges using 30min EEG [ Time Frame: 6 months ]
  11. The fractional anisotropy (FA) and mean diffusivity (MD) using diffusion tensor imaging (DTI) of magnetic resonance imaging (MRI) [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02613234


Contacts
Contact: Xin Wang, MD 86-021-64041990 ext 8022 wang.xin@zs-hospital.sh.cn
Contact: Jing Ding, MD 86-021-64041990 ext 2926 ding.jing@zs-hospital.sh.cn

Locations
China, Shanghai
Department of Neurology, Zhongshan Hospital, Fudan University, Shanghai, China Recruiting
Shanghai, Shanghai, China, 200032
Contact: Weifeng Peng, MD    86-021-64041990 ext 2976    peng.weifeng@zs-hospital.sh.cn   
Principal Investigator: Xin Wang, MD         
Sponsors and Collaborators
Shanghai Zhongshan Hospital
Investigators
Principal Investigator: Xin Wang, MD Shanghai Zhongshan Hospital

Responsible Party: Weifeng Peng, Vice Professor, Neurology Department, Investigator, Clinical Doctor, Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT02613234     History of Changes
Other Study ID Numbers: 128EEG
First Posted: November 24, 2015    Key Record Dates
Last Update Posted: March 24, 2016
Last Verified: March 2016

Keywords provided by Weifeng Peng, Shanghai Zhongshan Hospital:
Epilepsy
128-Channel EEG
Dipole Localization
Transcranial Direct Current Stimulation

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases