评估重复经颅磁刺激辅助康复缺血性卒中后轻瘫步态疗效的随机、单盲、平行对照、多中心研究

The effecicacy of repetitive transcranial magnetic stimulation on rehabilitation of mild hemiplegic gait after ischemic stroke:a randomized,single-blind,parallel-controlled,multicenter study

目的 探讨高频重复经颅磁刺激(rTMS)辅助缺血性卒中后轻瘫步态康复治疗的疗效。方法 选择复旦大学附属中山医院、上海市徐汇区中心医院、复旦大学附属华东医院收治的缺血性卒中后轻瘫步态患者23例,男19例、女4例,年龄35~75岁。随机分为真刺激组(给予真性rTMS治疗,11例)和伪刺激组(仅有声音,无有效rTMS治疗,12例)。两组患者分别接受连续4周的真或伪rTMS治疗,刺激靶点为卒中病灶侧下肢初级运动皮层(Leg-M1),频率为10 Hz,同时接受步态训练,治疗后共随访8周。分别于治疗前和治疗后第4、8、12周采用Tinetti平衡与步态量表对患者的步态和平衡状态进行评估;分别于治疗前和治疗后第4、12周采用简易智力状态检查(MMSE)量表、蒙特利尔认知评估(MoCA)量表评估患者的认知功能,采用汉密尔顿抑郁量表(HAMD)评估患者的抑郁情绪,采用工具性日常生活活动能力(IADL)量表评估患者的日常生活能力。记录各量表评分,以及治疗和随访期间不良事件发生情况。结果 两组间患者的年龄、性别构成,以及梗死部位的差异均无统计学意义(P值均>0.05)。两组治疗后第4、8、12周的Tinetti平衡量表评分、Tinetti步态量表评分、Tinetti量表总评分均显著高于同组治疗前(P值均<0.05);治疗后第4周,真刺激组Tinetti平衡量表评分显著高于伪刺激组(P<0.05);两组间治疗前和治疗后第8、12周的Tinetti平衡量表评分的差异均无统计学意义(P值均>0.05),两组间治疗前和治疗后第4、8、12周的Tinetti步态量表评分、Tinetti量表总评分的差异均无统计学意义(P值均>0.05)。两组间治疗前后MMSE量表、MoCA量表评分的差异均无统计学意义(P值均>0.05)。两组治疗后第4、12周的HAMD量表评分均显著低于同组治疗前(P值均<0.05),IADL量表评分均显著高于同组治疗前(P值均<0.05);两组间治疗前和治疗后第4、12周HAMD评分,IADL量表评分的差异均无统计学意义(P值均>0.05)。两组患者在治疗和随访期间均未发生不良事件。结论 针对缺血性卒中病灶侧Leg-M1区的高频rTMS可能在短期内提高患者的康复效率,更快地促进患者的平衡功能恢复,对卒中患者的认知、情绪等未见明显影响。

Objective To explore the efficacy of high-frequency repetitive transcranial magnetic stimulation(rTMS)in assisting the rehabilitation of gait in patients with mild hemiplegia after ischemic stroke.Methods A total of 23 patients with mild hemiplegic gait after ischemic stroke were selected from Zhongshan Hospital,Shanghai Xuhui District Central Hospital,and Huadong Hospital.There were 19 males and 4 females aged 35 to 75 years.The patients were randomly divided into an active stimulation group(n=11,receiving rTMS treatment)and a sham stimulation group(n=12,only receiving sound without effective rTMS treatment).Active and sham rTMS treatments were given for 4 consecutive weeks.The stimulation target was the primary motor cortex of the lower limb(Leg-M1)on the side of the stroke,with a frequency of 10 Hz.The patients in both groups received gait training simultaneously.The duration of follow-up was 8 weeks.The Tinetti balance and gait scale was used to assess the gait and balance status before treatment and at 4,8,and 12 weeks after treatment.The mini-mental state examination(MMSE),Montreal cognitive assessment(MoCA),Hamilton depression scale(HAMD),and instrument activities of daily living(IADL)were used to assess the cognitive function,emotions,and daily living abilities before treatment and at 4 and 12 weeks after treatment.Adverse events during treatment and follow-up period were recorded.Results There were no statistically significant differences in the age,gender composition,or infarct location between the two groups(all P>0.05).Tinetti balance score,gait score,and total Tinetti score at 4,8,and 12 weeks after treatment were significantly higher than those before treatment in both groups(all P<0.05).Tinetti balance score in the active stimulation group was significantly higher than that in the sham stimulation group at 4 weeks after treatment(P<0.05).There were no statistically significant differences in the Tinetti balance score between the two groups before treatment,at 8 and 12 weeks after treatment(all P>0.05).There were no statistically significant differences in the Tinetti gait score or total Tinetti score between the two groups before treatment,at 4,8,and 12 weeks after treatment(all P>0.05).There were no statistically significant differences in the MMSE,MoCA,HAMD or IADL score between the two groups before and after treatment(all P>0.05).The patients in both groups had lower HAMD score and IADL score at 4 and 12 weeks after treatment than before treatment(all P<0.05).No adverse events occurred during treatment and follow-up in either group.Conclusion High-frequency rTMS targeting the Leg-M1 on the side of ischemic stroke may improve the rehabilitation efficiency and promote balance function recovery in a short term.It has no significant impact on the cognitive function or emotions of stroke patients.