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经颅直流电刺激原发性感觉运动区对未经药物治疗的不宁腿综合征患者无效:一项概念验证性临床试验。

Transcranial direct current stimulation on primary sensorimotor area has no effect in patients with drug-naïve restless legs syndrome: a proof-of-concept clinical trial.

作者信息

Koo Yong Seo, Kim Sung Min, Lee Chany, Lee Byeong Uk, Moon Ye Ji, Cho Yong Won, Im Chang-Hwan, Choi Jeong Woo, Kim Kyung Hwan, Jung Ki-Young

机构信息

Department of Neurology, Korea University Medical Center Anam Hospital, Korea University College of Medicine, Seoul, South Korea.

Department of Neurology, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, South Korea.

出版信息

Sleep Med. 2015 Feb;16(2):280-7. doi: 10.1016/j.sleep.2014.07.032. Epub 2014 Dec 2.

DOI:10.1016/j.sleep.2014.07.032
PMID:25576136
Abstract

OBJECTIVE

To evaluate the efficacy of transcranial direct current stimulation (tDCS) in people with drug-naïve restless legs syndrome (RLS).

METHODS

A two-week, double-blind, randomized, sham-controlled trial was performed. Thirty-three females with RLS were recruited. Participants received five sessions of tDCS using cathodal, anodal or sham stimulation. They were assessed at baseline (T0), three days (T1) and 13 days (T2) after the end of tDCS. Primary outcomes included the International RLS Group Rating Scale (IRLS) and the Clinical Global Impressions-Improvement (CGI-I). Secondary outcomes included the Patient Global Impression scale, the Pittsburgh Sleep Quality Index, the Medical Outcome Study sleep subscales, and the Beck Depression Inventory. Objective neurophysiological changes were assessed using event-related desynchronization/synchronization (ERD/ERS) of electroencephalography.

RESULTS

The changes in the IRLS scores, as well as the responder rate in the CGI-I scale, did not differ significantly among the groups. There was also no significant difference in any of the secondary outcome measures and ERD/ERS among the groups.

CONCLUSIONS

Transcranial direct current stimulation with electrodes on the sensorimotor areas showed no significant effect in people with drug-naïve RLS.

摘要

目的

评估经颅直流电刺激(tDCS)对未使用过药物的不安腿综合征(RLS)患者的疗效。

方法

进行了一项为期两周的双盲、随机、假刺激对照试验。招募了33名患有RLS的女性。参与者接受了五次使用阴极、阳极或假刺激的tDCS治疗。在tDCS结束后的基线(T0)、三天(T1)和13天(T2)对她们进行评估。主要结局指标包括国际不安腿综合征小组评定量表(IRLS)和临床总体印象改善量表(CGI-I)。次要结局指标包括患者总体印象量表、匹兹堡睡眠质量指数、医学结局研究睡眠分量表和贝克抑郁量表。使用脑电图的事件相关去同步化/同步化(ERD/ERS)评估客观神经生理变化。

结果

IRLS评分的变化以及CGI-I量表中的应答率在各组之间没有显著差异。各组之间在任何次要结局指标和ERD/ERS方面也没有显著差异。

结论

在感觉运动区域放置电极进行经颅直流电刺激对未使用过药物的RLS患者没有显著效果。

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