Overview
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.
Description
All participants underwent a medical evaluation that included physical examination and routine laboratory studies before and after high definition transcranial direct current stimulation (HD-tDCS) treatment.Upon meeting the inclusion criteria and providing informed consent, each participant will complete clinical assessments by a trained investigator and HD-tDCS treatment at Anhui mental health centre.
At least 90 participants were randomized (1:1:1) to receive "bilateral active" ,"Unilateral active" or "Sham" treatment protocol. The left electrical stimulation cathode was placed over CP5 with return electrodes placed at FT7, C1, P03 and P9 . The right electrical stimulation cathode was placed over CP6 with return electrodes placed at FT8, C2, PO4 and P10 .
In the bilateral treatment group, HD-tDCS treatment was placed on the left and right sides of the brain, at least eight hours apart. Twenty 2-mA sessions (ramp-up and ramp-down periods of 30 and 30 seconds, respectively) were applied for 30 minutes,twice a day over 10 consecutive workdays. In the unilateral treatment group, HD-tDCS treatment based on Epileptic discharge is placed on either the left or right side of the brain.Ten 2-mA sessions were applied for 30 minutes,once a day over 10 consecutive workdays.Sham HD-tDCS was delivered using the same protocol and current intensity, but the period of active stimulation was only during the ramp-up and ramp-down periods of 30 and 30 seconds.
Before and after the tDCS treatment, the patients had receiving a battery measure of neuropsychological tests, Magnetic resonance imaging scan in multimodalities, VEEG and Resting motor threshold.
The clinical symptom of participants were followed 4 weeks and 12 weeks after the last treatment.
Eligibility
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.