High Definition Transcranial Direct Current Stimulation (HD-tDCS) for Refractory Epilepsy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorAnhui Medical University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Active Comparator: Unilateral real High definition transcranial direct current stimulation

    Device

    Improvement of cortical excitability, unilateral stimulation was effective, and no side effects were observed

  • Active Comparator: Bilateral real High definition transcranial direct current stimulation

    Device

    Improved 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

    Device

    The sham stimulation is mainly used for blank control, control variables, and exclude the interference of other factors

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Unilateral real High definition transcranial direct current stimulationActive comparator 1 intervention
Group B: Bilateral real High definition transcranial direct current stimulationActive comparator 1 intervention
Group C: Sham High definition transcranial direct current stimulationSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline and 10 workdays post-treatment,and follow-up to 1 months and 3 months

Secondary outcomes

1

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

Time frame
Baseline and 10 workdays post-treatment,and follow-up to 1 months and 3 months
2

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.

Time frame
Baseline and 10 workdays post-treatment,and follow-up to 1 months and 3 months
3

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.

Time frame
Baseline and 10 workdays post-treatment,and follow-up to 1 months and 3 months
4

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

Time frame
Baseline and 10 workdays post-treatment,and follow-up to 1 months and 3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.