Elsner Bernhard, Kugler Joachim, Pohl Marcus, Mehrholz Jan
Department of Public Health, Dresden Medical School, Technical University Dresden, Fetscherstr. 74, Dresden, Sachsen, Germany, 01307.
Cochrane Database Syst Rev. 2016 Jul 18;7(7):CD010916. doi: 10.1002/14651858.CD010916.pub2.
Idiopathic Parkinson's disease (IPD) is a neurodegenerative disorder, with the severity of the disability usually increasing with disease duration. IPD affects patients' health-related quality of life, disability, and impairment. Current rehabilitation approaches have limited effectiveness in improving outcomes in patients with IPD, but a possible adjunct to rehabilitation might be non-invasive brain stimulation by transcranial direct current stimulation (tDCS) to modulate cortical excitability, and hence to improve these outcomes in IPD.
To assess the effectiveness of tDCS in improving motor and non-motor symptoms in people with IPD.
We searched the following databases (until February 2016): the Cochrane Central Register of Controlled Trials (CENTRAL; the Cochrane Library ; 2016 , Issue 2), MEDLINE, EMBASE, CINAHL, AMED, Science Citation Index, the Physiotherapy Evidence Database (PEDro), Rehabdata, and Inspec. In an effort to identify further published, unpublished, and ongoing trials, we searched trial registers and reference lists, handsearched conference proceedings, and contacted authors and equipment manufacturers.
We included only randomised controlled trials (RCTs) and randomised controlled cross-over trials that compared tDCS versus control in patients with IPD for improving health-related quality of life , disability, and impairment.
Two review authors independently assessed trial quality (JM and MP) and extracted data (BE and JM). If necessary, we contacted study authors to ask for additional information. We collected information on dropouts and adverse events from the trial reports.
We included six trials with a total of 137 participants. We found two studies with 45 participants examining the effects of tDCS compared to control (sham tDCS) on our primary outcome measure, impairment, as measured by the Unified Parkinson's Disease Rating Scale (UPDRS). There was very low quality evidence for no effect of tDCS on change in global UPDRS score ( mean difference (MD) -7.10 %, 95% confidence interval (CI -19.18 to 4.97; P = 0.25, I² = 21%, random-effects model). However, there was evidence of an effect on UPDRS part III motor subsection score at the end of the intervention phase (MD -14.43%, 95% CI -24.68 to -4.18; P = 0.006, I² = 2%, random-effects model; very low quality evidence). One study with 25 participants measured the reduction in off and on time with dyskinesia, but there was no evidence of an effect (MD 0.10 hours, 95% CI -0.14 to 0.34; P = 0.41, I² = 0%, random-effects model; and MD 0.00 hours, 95% CI -0.12 to 0.12; P = 1, I² = 0%, random- effects model, respectively; very low quality evidence).Two trials with a total of 41 participants measured gait speed using measures of timed gait at the end of the intervention phase, revealing no evidence of an effect ( standardised mean difference (SMD) 0.50, 95% CI -0.17 to 1.18; P = 0.14, I² = 11%, random-effects model; very low quality evidence). Another secondary outcome was health-related quality of life and we found one study with 25 participants reporting on the physical health and mental health aspects of health-related quality of life (MD 1.00 SF-12 score, 95% CI -5.20 to 7.20; I² = 0%, inverse variance method with random-effects model; very low quality evidence; and MD 1.60 SF-12 score, 95% CI -5.08 to 8.28; I² = 0%, inverse variance method with random-effects model; very low quality evidence, respectively). We found no study examining the effects of tDCS for improving activities of daily living. In two of six studies, dropouts , adverse events, or deaths occurring during the intervention phase were reported. There was insufficient evidence that dropouts , adverse effects, or deaths were higher with intervention (risk difference (RD) 0.04, 95% CI -0.05 to 0.12; P = 0.40, I² = 0%, random-effects model; very low quality evidence).We found one trial with a total of 16 participants examining the effects of tDCS plus movement therapy compared to control (sham tDCS) plus movement therapy on our secondary outcome, gait speed at the end of the intervention phase, revealing no evidence of an effect (MD 0.05 m/s, 95% CI -0.15 to 0.25; inverse variance method with random-effects model; very low quality evidence). We found no evidence of an effect regarding differences in dropouts and adverse effects between intervention and control groups (RD 0.00, 95% CI -0.21 to 0.21; Mantel-Haenszel method with random-effects model; very low quality evidence).
AUTHORS' CONCLUSIONS: There is insufficient evidence to determine the effects of tDCS for reducing off time ( when the symptoms are not controlled by the medication) and on time with dyskinesia ( time that symptoms are controlled but the person still experiences involuntary muscle movements ) , and for improving health- related quality of life, disability, and impairment in patients with IPD. Evidence of very low quality indicates no difference in dropouts and adverse events between tDCS and control groups.
特发性帕金森病(IPD)是一种神经退行性疾病,残疾严重程度通常随病程延长而增加。IPD会影响患者与健康相关的生活质量、残疾状况和功能损害。目前的康复方法在改善IPD患者的预后方面效果有限,但经颅直流电刺激(tDCS)这种非侵入性脑刺激可能是康复的一种辅助手段,它可以调节皮质兴奋性,从而改善IPD患者的这些预后。
评估tDCS改善IPD患者运动和非运动症状的有效性。
我们检索了以下数据库(截至2016年2月):Cochrane对照试验中央注册库(CENTRAL;Cochrane图书馆;2016年第2期)、MEDLINE、EMBASE、CINAHL、AMED、科学引文索引、物理治疗证据数据库(PEDro)、Rehabdata和Inspec。为了识别更多已发表、未发表和正在进行的试验,我们检索了试验注册库和参考文献列表,手工检索了会议论文集,并联系了作者和设备制造商。
我们仅纳入了随机对照试验(RCT)和随机对照交叉试验,这些试验比较了tDCS与对照组对IPD患者改善与健康相关的生活质量、残疾状况和功能损害的效果。
两位综述作者独立评估试验质量(JM和MP)并提取数据(BE和JM)。如有必要,我们联系研究作者以获取更多信息。我们从试验报告中收集了关于脱落和不良事件的信息。
我们纳入了6项试验,共137名参与者。我们发现两项研究,共45名参与者,比较了tDCS与对照组(假tDCS)对我们的主要结局指标——功能损害(通过统一帕金森病评定量表(UPDRS)测量)的影响。关于tDCS对全球UPDRS评分变化无影响的证据质量非常低(平均差(MD)-7.10%,95%置信区间(CI)-19.18至4.97;P = 0.25,I² = 21%,随机效应模型)。然而,有证据表明在干预阶段结束时对UPDRS第三部分运动子量表评分有影响(MD -14.43%,95% CI -24.68至-4.18;P = 0.006,I² = 2%,随机效应模型;证据质量非常低)。一项有25名参与者的研究测量了异动症的关期和开期时间的减少,但没有证据表明有影响(MD 0.10小时,95% CI -0.14至0.34;P = 0.41,I² = 0%,随机效应模型;以及MD 0.00小时,95% CI -0.12至0.12;P = 1,I² = 0%,随机效应模型,分别;证据质量非常低)。两项共41名参与者的试验在干预阶段结束时使用定时步态测量法测量了步态速度,没有发现有影响的证据(标准化平均差(SMD)0.50,95% CI -0.17至1.18;P = 0.14,I² = 11%,随机效应模型;证据质量非常低)。另一个次要结局是与健康相关的生活质量,我们发现一项有25名参与者的研究报告了与健康相关生活质量的身体健康和心理健康方面(MD 1.00 SF - 12评分,95% CI -5.20至7.20;I² = 0%,随机效应模型的逆方差法;证据质量非常低;以及MD 1.60 SF - 12评分,95% CI -5.08至8.28;I² = 0%,随机效应模型的逆方差法;证据质量非常低,分别)。我们没有发现研究tDCS改善日常生活活动效果的试验。在6项研究中的2项中,报告了干预阶段出现的脱落、不良事件或死亡情况。没有足够的证据表明干预组的脱落、不良反应或死亡情况更高(风险差(RD)0.04,95% CI -0.05至0.12;P = 0.40,I² = 0%,随机效应模型;证据质量非常低)。我们发现一项共16名参与者的试验比较了tDCS加运动疗法与对照组(假tDCS)加运动疗法对我们的次要结局——干预阶段结束时的步态速度的影响,没有发现有影响的证据(MD 0.05 m/s,95% CI -0.15至0.25;随机效应模型的逆方差法;证据质量非常低)。我们没有发现干预组和对照组在脱落和不良反应差异方面有影响的证据(RD 0.00,95% CI -0.21至0.21;随机效应模型的Mantel - Haenszel法;证据质量非常低)。
没有足够的证据来确定tDCS对减少关期(症状未被药物控制的时间)和异动症开期(症状被控制但患者仍经历不自主肌肉运动的时间)以及改善IPD患者与健康相关的生活质量、残疾状况和功能损害的效果。质量非常低的证据表明tDCS组和对照组在脱落和不良事件方面没有差异。