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

NCT02613234 | Completed

• 1 other identifier: 128EEG
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Epilepsy

Keywords

Epilepsy; 128-Channel EEG; Dipole Localization; Transcranial Direct Current Stimulation

Outcome Measures

Primary Outcomes (1)

• Seizure frequency

  The frequency of seizures using diary

  6 months

Secondary Outcomes (11)

• MMSE

  6 months

• MoCA

  6 months

• AVLT

  6 months

• SDMT

  6 months

• CWT

  6 months

Study Arms (2)

Experimental Group

EXPERIMENTAL

Active Intervention on brain waves by cathode tDCS

Device: cathode tDCS

Control Group

SHAM COMPARATOR

Sham Intervention on brain waves by cathode tDCS

Device: Sham cathode tDCS

Interventions

cathode tDCS DEVICE

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).

Experimental Group

Sham cathode tDCS DEVICE

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).

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Xin Wang, MD

  Shanghai Zhongshan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Professor, Neurology Department, Investigator, Clinical Doctor

Study Record Dates

• First Submitted: November 15, 2015
• First Posted: November 24, 2015
• Study Start: April 1, 2016
• Primary Completion: March 1, 2019
• Study Completion: May 1, 2019
• Last Updated: February 25, 2020

Record last verified: 2020-02

Locations

CN (1)