The Efficacy, Safety and Mechanism of High Definition Transcranial Direct Current Stimulation (HD-tDCS) in the Treatment of Refractory Epilepsy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- The changes of Epilepsy diary
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Unilateral real High definition transcranial direct current stimulation
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 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.
干预措施: Active Comparator: Unilateral real High definition transcranial direct current stimulation (Device)
Bilateral real High definition transcranial direct current stimulation
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.
干预措施: Active Comparator: Bilateral real High definition transcranial direct current stimulation (Device)
Sham High definition transcranial direct current stimulation
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.
The 30 subjects were randomly divided into two groups, 15 receiving bilateral Sham HD-tDCS and 15 receiving unilateral Sham HD-tDCS.
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.
干预措施: Sham Comparator: Sham High definition transcranial direct current stimulation (Device)
结局指标
主要结局
The changes of Epilepsy diary
时间窗: Baseline and 10 workdays post-treatment,and follow-up to 1 months and 3 months
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.
次要结局
- The changes of resting motor threshold(RMT）(Baseline and 10 workdays post-treatment,and follow-up to 1 months and 3 months)
- The changes of GABA-B receptor-mediated long septal cortical inhibition (LICI).(Baseline and 10 workdays post-treatment,and follow-up to 1 months and 3 months)
- The changes of MoCA Score(Baseline and 10 workdays post-treatment,and follow-up to 1 months and 3 months)
- The changes of TMT (Trail Making Test) Score(Baseline and 10 workdays post-treatment,and follow-up to 1 months and 3 months)
- The changes of VEEG(Baseline and 10 workdays post-treatment,and follow-up to 1 months and 3 months)
- The changes of Chinese auditory learning test Score(Baseline and 10 workdays post-treatment,and follow-up to 1 months and 3 months)
- The changes of GABA-A receptor-mediated short septal cortical inhibition (SICI)(Baseline and 10 workdays post-treatment,and follow-up to 1 months and 3 months)
- The changes of Hamilton Anxiety Scale (HAMA) Score(Baseline and 10 workdays post-treatment,and follow-up to 1 months and 3 months)
- The changes of Face associative memory Score(Baseline and 10 workdays post-treatment,and follow-up to 1 months and 3 months)
- The changes of resting-state functional connectivity(Baseline and 10 workdays post-treatment,and follow-up to 1 months and 3 months)
- The changes of glutamate receptor-mediated intracortical facilitation (ICF)(Baseline and 10 workdays post-treatment,and follow-up to 1 months and 3 months)
- The changes of Hamilton Depression Rating Scale (HAMD) Score(Baseline and 10 workdays post-treatment,and follow-up to 1 months and 3 months)
研究者
WANG KAI
Director of medical psychological department, Anhui Medical University
Anhui Medical University