Epilepsy Clinical Trial
Official title:
Efficacy of 128-channel Electroencephalograph Combined With BESA Dipole Localization Method and Intervention on Brain Waves for Epilepsy
NCT number | NCT02613234 |
Other study ID # | 128EEG |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 1, 2016 |
Est. completion date | May 1, 2019 |
Verified date | February 2020 |
Source | Shanghai Zhongshan Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 31 |
Est. completion date | May 1, 2019 |
Est. primary completion date | March 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
China | Department of Neurology, Zhongshan Hospital, Fudan University, Shanghai, China | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Zhongshan Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Seizure frequency | The frequency of seizures using diary | 6 months | |
Secondary | MMSE | The cognitive function using Mini-mental state examination | 6 months | |
Secondary | MoCA | The cognitive function using Montreal cognitive assessment | 6 months | |
Secondary | AVLT | The cognitive function using auditory verbal learning test ( | 6 months | |
Secondary | SDMT | The cognitive function using symbol digit modalities test | 6 months | |
Secondary | CWT | The cognitive function using Stroop color word test | 6 months | |
Secondary | EPQ | The psychology evaluation using Eysenck personality questionnaire | 6 months | |
Secondary | HAMD-17 | The psychology evaluation using Hamilton rating scale for depression-17 | 6 months | |
Secondary | SCL-90 | The psychology evaluation using symptom check list-90 | 6 months | |
Secondary | QOLIE-31 | The life quality using quality of life in epilepsy-31 | 6 months | |
Secondary | Epileptiform discharges | The number of epileptiform discharges using 30min EEG | 6 months | |
Secondary | fMRI analysis | Graph theory-based fMRI analysis | 6 months |
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