The Effect of Transcranial Direct Current Stimulation Combined With Repetitive Transcranial Magnetic Stimulation on Motor Function Rehabilitation in Patients With Locked-in Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 主要终点
- the efficiency
研究概览
简要总结
This study was a multicenter randomized double-blind, sham controlled trial initiated by Zhujiang Hospital of Southern Medical University. It is planned to recruit 72 eligible patients with atresia syndrome and randomly divide them into four groups according to the ratio of 1:1:1:1. Group 1 received the sequential stimulation of true tDCS and true rTMS, group 2 received the stimulation of sham tDCS and then true rTMS, group 3 received the stimulation of true tDCS and then sham rTMS, and group 4 received the simulated stimulation of sham tDCS and sham rTMS. The patients were treated for 4 weeks, 5 days a week, once a day in the bilateral M1 area, and in the morning and afternoon on the left and right sides respectively. Each tDCS and rTMS treatment lasted for 20 minutes.Various indicators were evaluated before and after the intervention, and the observation and follow-up were conducted 1, 3, and 6 months after the intervention.
详细描述
This study was a multicenter randomized double-blind, sham controlled trial initiated by Zhujiang Hospital of Southern Medical University. It is planned to recruit 72 eligible patients with atresia syndrome and randomly divide them into four groups according to the ratio of 1:1:1:1. Group 1 received the sequential stimulation of true tDCS and true rTMS, group 2 received the stimulation of sham tDCS and then true rTMS, group 3 received the stimulation of true tDCS and then sham rTMS, and group 4 received the simulated stimulation of sham tDCS and sham rTMS. The patients were treated for 4 weeks, 5 days a week, once a day in the bilateral M1 area, and in the morning and afternoon on the left and right sides respectively. Transcranial direct current stimulation (tDCS) was performed using a 2 Ma DC stimulator. The anode was placed in the M1 area of the target side (corresponding to the electrode position c3/c4 of the 10-20 EEG system), and the cathode was placed on the contralateral shoulder. The left side was done in the morning and the right side was done in the afternoon. Each tDCS treatment lasted for 20 minutes. The sham stimulation was given current stimulation for 30 seconds and gradually decreased to 0. Repetitive transcranial magnetic stimulation (rTMS) intervention was performed 20 minutes after the end of TDCS treatment. RTMS uses an 8-shaped coil placed in the M1 area of the target side to stimulate at a frequency of 10Hz. Each treatment contains 1600 pulses of stimulation for 4 seconds, with an interval of 26 seconds. The total number of pulses is 1600, lasting for 20 minutes. Each time is once a day in the M1 area of both sides. The sequence is the same as that of TDCS, 5 days a week, and the same lasts for 4 weeks. The stimulation coil was placed at 90 degrees during sham stimulation. Various indicators were evaluated before and after the intervention, and the observation and follow-up were conducted 1, 3, and 6 months after the intervention.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients were 18-70 years old, clinically diagnosed as classic or incomplete atresia syndrome, and the onset time was 6 weeks-1 year.
- •Clear consciousness, effective communication and command response through eye movement or other established methods.
- •No drugs (sodium, calcium channel blockers or sedatives) that may affect neuromuscular function or brain stimulation effect were used, or the drugs were stably stopped for more than 1 week before enrollment.
- •The patient or his legal guardian signed the informed consent form and agreed to cooperate in completing all test procedures and evaluations.
排除标准
- •Metal implants (such as cardiac pacemaker, intracranial metal clip, etc.), electronic equipment or other TMS contraindications.
- •Complicated with severe cognitive impairment (such as dementia) or unable to cooperate to complete the assessment scale test.
- •Have a history of severe cardiopulmonary dysfunction, mental illness and seizures.
- •There are other neurodegenerative diseases that affect the recovery of motor function (such as amyotrophic lateral sclerosis, etc.)
- •Recently (within 1 month) participated in other clinical trials related to neuromodulation therapy.
研究组 & 干预措施
Group 1
true tDCS and true rTMS
干预措施: Repetitive transcranial magnetic stimulation (Device)
Group 1
true tDCS and true rTMS
干预措施: Transcranial direct current stimulation (Device)
Group 2
sham tDCS and true rTMS
干预措施: Repetitive transcranial magnetic stimulation (Device)
Group 2
sham tDCS and true rTMS
干预措施: Transcranial direct current stimulation (Device)
Group 3
true tDCS and sham rTMS
干预措施: Repetitive transcranial magnetic stimulation (Device)
Group 3
true tDCS and sham rTMS
干预措施: Transcranial direct current stimulation (Device)
Group 4
sham tDCS and sham rTMS
干预措施: Repetitive transcranial magnetic stimulation (Device)
Group 4
sham tDCS and sham rTMS
干预措施: Transcranial direct current stimulation (Device)
结局指标
主要结局
the efficiency
时间窗: Before intervention, 1-2 days after intervention, and 1, 3, and 6 months after intervention
An increase of 5 points in the Fugl Meyer Assessment (FMA) score or an increase of one level in the House Brackmann Facial Nerve Grading Scale (HBFNGS) score is considered effective through behavioral assessment.
次要结局
- FMA(Before intervention, 1-2 days after intervention, and 1, 3, and 6 months after intervention)
- HBFNGS(Before the intervention starts, 1-2 days after the intervention ends, and 1, 3, and 6 months after the intervention ends)
- Modified Barthel Index(Before intervention, 1-2 days after intervention, and 1, 3, and 6 months after intervention)
- Motor evoked potential（Mep）(Before intervention, 1-2 days after intervention)
- Assessment of TMS-EEG（TEPs）(Before intervention and 1-2 days after intervention)
- Assessment of TMS-EEG（oscillation analysis）(Before intervention and 1-2 days after intervention)
研究者
Qiuyou Xie
principal investigator
Zhujiang Hospital