非随机重复经颅磁刺激治疗Rett综合征患儿有效性的临床试验

目的 分析重复经颅磁刺激(rTMS)治疗Rett综合征的有效性,为临床治疗提供依据。方法 2015年1月—2018年4月收集符合入组标准的RTT患儿17例,将其非随机分为TMS组(用rTMS治疗的干预组,7例)和对照组(10例),分别接受为期6个月的rTMS治疗和门诊常规随访。所有患儿均接受MECP2基因检测,并于入组时及6个月时分别接受Griffiths精神发育量表-中文版(GDS-C)、Peabody发育运动量表(PDMS)、儿童睡眠习惯问卷(CSHQ)、闪光视觉诱发电位(FVEP)及脑干听觉诱发电位(BAEP)的检查。方法 1)TMS组与对照组患儿在整体发育、运动能力方面均呈现明显的退行性变化过程,两组比较差异无统计学意义(P>0.05)。2)睡眠方面,TMS组及对照组患儿睡眠时间均较短,经过6个月的rTMS干预后,与对照组患儿相比,TMS组患儿平均睡眠时间延长,但差异无统计学意义TMS组差值=(0.83± 0.97)h vs.对照组差值=(-0.40±1.20)h,P>0.05]。3)视听觉诱发电位检测提示,两组患儿治疗前后及组间比较亦无明显差异。4)TMS治疗过程中安全,未报告不良事件。结论 rTMS可能有延长RTT患儿睡眠时间、改善睡眠质量的作用。TMS治疗对于RTT患儿的智力和运动发育水平的倒退进程无改善作用,对RTT患儿的视觉及听觉电生理指标无明显影响。RTT患儿使用rTMS 过程中无严重不良反应。

Non-randomized clinical trial of repetitive transcranial magnetic stimulation in the treatment of children with Rett syndrome

Objectives To investigate the efficacy of repetitive transcranial magnetic stimulation(rTMS) in the treatment of Rett syndrome(RTT),so as to provide reference for clinical treatment. Methods Totally 17 children with Rett syndrome who met the criterion were enrolled in this study from January 2015 to April 2018,and were non-randomly divided into the TMS group(n=7) and control group(n=10). The TMS group was given rTMS for 6 months,while the control group received routine follow-up. All children were tested for MECP2 gene and were assessed by Griffiths Mental Development Scale-Chinese Version(GDS-C),Peabody Development Motor Scales(PDMS),Children′s Sleep Habits Questionnaire(CSHQ),flash visual evoked potential(FVEP) and brainstem auditory evoked potential(BAEP) at admission and 6 months respectively. Results 1) The overall development and motor ability of the children in TMS group and control group showed obviously degenerative changes,but the differences between the two groups were not significant(P＞0.05). 2) The sleep duration of children in TMS group and control group was shorter. After 6 months of rTMS intervention in TMS group,the average sleep duration of children in TMS group was longer than that of control group,but there was no significant difference between the two groupsΔTMS group:(0.83±0.97) h vs. Δ control group:(-0.40±1.20) h,P＞0.05]. 3) There were no significant changes on the results of FVEP and BAEP before and after treatment,so was the difference between the two groups(P＞0.05). 4) rTMS was safe during treatment and no adverse events were reported. Conclusions Repeated transcranial magnetic stimulation may prolong the sleep duration and improve the quality of sleep in RTT children. Moreover,rTMS treatment has no significant effect on the progression of mental and motor developmental levels in RTT children,as well as the parameters of FVEP and BAEP. Meanwhile,there are no serious adverse reactions during the use of rTMS