About this trial
To observe the clinical effect and safety of transcranial electrical stimulation on patients with refractory epilepsy before and after treatment and analyze its therapeutic mechanism.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Clinical diagnosis of refractory epilepsy
Right-handed and aged 18-50 years old and primary school education or above;
No major neurological or mental illness, no head injury, alcohol dependence or drug dependence;
During the experiment, the subjects did not smoke, drink, get sick and take psychotropic drugs, and there were no major life events that caused mood changes.
Disqualifiers
organic brain injury, neurological diseases or serious physical diseases;
Have a history of substance abuse and drug dependence, or have used antipsychotic drugs in the past three months, and have serious suicidal tendencies;
There are contraindications for MRI or EEG or transcranial magnetic stimulation.
Trial design
Parallel
Treatments tested in this trial
Active Comparator: Unilateral real High definition transcranial direct current stimulation
DeviceImprovement of cortical excitability, unilateral stimulation was effective, and no side effects were observed
Active Comparator: Bilateral real High definition transcranial direct current stimulation
DeviceImproved cortical excitability, the effect was more obvious than unilateral stimulation, the effect lasted longer, and no side effects were observed
Sham Comparator: Sham High definition transcranial direct current stimulation
DeviceThe sham stimulation is mainly used for blank control, control variables, and exclude the interference of other factors
Treatment groups
Trial outcomes
Primary outcomes
The changes of Epilepsy diary
The reduction of seizure frequency in patients with epilepsy will constitute the primary outcome measure to evaluate the efficacy of HD-tDCS, reflecting the improvement of patients' clinical symptoms. Patients and family members are asked to keep an epilepsy diary to record the time, duration, and status of the seizure.
Secondary outcomes
The changes of VEEG
The number of discharges recorded by VEEG before and after the intervention, as well as the decrease in epileptiform discharge index, were used as indicators to evaluate the improvement of epilepsy symptoms
The changes of resting-state functional connectivity
the change of resting-state functional connectivity strength between stimulated target and the whole brain areas will be measured by functional MRI and resting-state EEG.
The changes of resting motor threshold(RMT)
Previous studies have found that the resting movement threshold is an effective measure of cortical excitability in epilepsy patients, and can better predict the therapeutic effect. An elevated resting movement threshold indicates that the treatment is responding.
The changes of glutamate receptor-mediated intracortical facilitation (ICF)
ICF is a 120% RMT stimulation administered 15 ms after 90% RMT intensity stimulation, glutamate receptor-mediated intracortical promotion
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