一项双盲、假对照的试验,在患有抽动症和慢性抽动障碍的个体中,家庭给予有节奏的10赫兹正中神经刺激,以减少抽动,并抑制抽动的冲动

IF 2 4区 心理学 Q2 PSYCHOLOGY
Barbara Morera Maiquez, Caitlin Smith, Katherine Dyke, Chia-Ping Chou, Belinda Kasbia, Ciara McCready, Hannah Wright, Jessica K. Jackson, Isabel Farr, Erika Badinger, Georgina M. Jackson, Stephen R. Jackson
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引用次数: 0

摘要

抽动秽语综合征(TS)和慢性抽动障碍(CTD)是儿童期发病的以抽动为特征的神经系统疾病;重复的、无目的的、持续时间短的动作或声音,一天中可以发生多次。目前,抽动障碍的有效治疗是一个相当未满足临床需求的领域。我们的目的是评估家庭给药的神经调节治疗抽动症的疗效,包括通过佩戴在手腕上的可穿戴“手表状”设备传递正中神经刺激(MNS)的节律脉冲序列。我们在英国范围内进行了一项平行双盲假对照试验,以减少抽动障碍患者的抽动。该装置被编程为每天向正中神经提供有节奏的(10 Hz)低强度(1-19 mA)电刺激,持续预定的持续时间,并打算由每位参与者在家中每天使用一次,每周5天,持续4周。在2022年3月18日至2022年9月26日期间,135名参与者(每组45人)最初使用分层随机分配到以下组之一;积极的刺激;假刺激或等待名单(即正常治疗)对照组。招募的参与者是确诊或疑似TS/CTD的个体,年龄在12岁或以上,伴有中度至重度抽搐。参与测量结果收集或处理和评估结果的研究人员,以及活跃组和假组的参与者及其法定监护人都对小组分配不知情。用于评估刺激“离线”或治疗效果的主要结果测量是在4周刺激结束时评估的耶鲁全球抽动严重程度量表-总抽动严重程度评分(YGTSS-TTSS)。用于评估刺激“在线”效果的主要结果指标是抽搐频率,以观察到的每分钟抽搐次数(TPM)来衡量,该指标基于对刺激过程中获得的每日视频记录的盲目分析。结果显示,刺激4周后,主动刺激组的抽动严重程度(YGTSS-TTSS)比假刺激组和候补对照组的2.13/2.11分降低了7.1分(降低了35个百分位数)。与假刺激组和候补组相比,主动刺激组的YGTSS-TTSS降低幅度更大,具有临床意义(效应值= 0.5),统计学意义(p = 0.02),两者之间没有差异(效应值= - 0.03)。此外,视频记录的盲法分析表明,与假刺激(- 7.7 TPM)相比,主动刺激期间抽搐频率(每分钟抽搐次数)大幅降低(- 15.6 TPM)。这一差异具有统计学意义(p < .03),并且具有临床意义的抽动频率降低(p < .03)。这些发现表明,通过可穿戴式腕带设备进行家庭节律性MNS治疗有可能成为一种有效的社区抽动障碍治疗方法。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
A double-blind, sham-controlled, trial of home-administered rhythmic 10-Hz median nerve stimulation for the reduction of tics, and suppression of the urge-to-tic, in individuals with Tourette syndrome and chronic tic disorder

Tourette syndrome (TS) and chronic tic disorder (CTD) are neurological disorders of childhood onset characterized by the occurrence of tics; repetitive, purposeless, movements or vocalizations of short duration which can occur many times throughout a day. Currently, effective treatment for tic disorders is an area of considerable unmet clinical need. We aimed to evaluate the efficacy of a home-administered neuromodulation treatment for tics involving the delivery of rhythmic pulse trains of median nerve stimulation (MNS) delivered via a wearable ‘watch-like’ device worn at the wrist. We conducted a UK-wide parallel double-blind sham-controlled trial for the reduction of tics in individuals with tic disorder. The device was programmed to deliver rhythmic (10 Hz) trains of low-intensity (1–19 mA) electrical stimulation to the median nerve for a pre-determined duration each day, and was intended to be used by each participant in their home once each day, 5 days each week, for a period of 4 weeks. Between 18th March 2022 and 26th September 2022, 135 participants (45 per group) were initially allocated, using stratified randomization, to one of the following groups; active stimulation; sham stimulation or to a waitlist (i.e. treatment as usual) control group. Recruited participants were individuals with confirmed or suspected TS/CTD aged 12 years of age or upward with moderate to severe tics. Researchers involved in the collection or processing of measurement outcomes and assessing the outcomes, as well as participants in the active and sham groups and their legal guardians were all blind to the group allocation. The primary outcome measure used to assess the ‘offline’ or treatment effect of stimulation was the Yale Global Tic Severity Scale–Total Tic Severity Score (YGTSS–TTSS) assessed at the conclusion of 4 weeks of stimulation. The primary outcome measure used to assess the ‘online’ effects of stimulation was tic frequency, measured as the number of tics per minute (TPM) observed, based upon blind analysis of daily video recordings obtained while stimulation was delivered. The results demonstrated that after 4-week stimulation, tic severity (YGTSS-TTSS) had reduced by 7.1 points (35 percentile reduction) for the active stimulation group compared to 2.13/2.11 points for the sham stimulation and waitlist control groups. The reduction in YGTSS–TTSS for the active stimulation group was substantially larger, clinically meaningful (effect size = .5) and statistically significant (p = .02) compared to both the sham stimulation and waitlist control groups, which did not differ from one another (effect size = −.03). Furthermore, blind analyses of video recordings demonstrated that tic frequency (tics per minute) reduced substantially (−15.6 TPM) during active stimulation compared to sham stimulation (−7.7 TPM). This difference represents a statistically significant (p < .03) and clinically meaningful reduction in tic frequency (>25 percentile reduction: effect size = .3). These findings indicate that home-administered rhythmic MNS delivered through a wearable wrist-worn device has the potential to be an effective community-based treatment for tic disorders.

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来源期刊
Journal of Neuropsychology
Journal of Neuropsychology 医学-心理学
CiteScore
4.50
自引率
4.50%
发文量
34
审稿时长
>12 weeks
期刊介绍: The Journal of Neuropsychology publishes original contributions to scientific knowledge in neuropsychology including: • clinical and research studies with neurological, psychiatric and psychological patient populations in all age groups • behavioural or pharmacological treatment regimes • cognitive experimentation and neuroimaging • multidisciplinary approach embracing areas such as developmental psychology, neurology, psychiatry, physiology, endocrinology, pharmacology and imaging science The following types of paper are invited: • papers reporting original empirical investigations • theoretical papers; provided that these are sufficiently related to empirical data • review articles, which need not be exhaustive, but which should give an interpretation of the state of research in a given field and, where appropriate, identify its clinical implications • brief reports and comments • case reports • fast-track papers (included in the issue following acceptation) reaction and rebuttals (short reactions to publications in JNP followed by an invited rebuttal of the original authors) • special issues.
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