Remotely supervised at-home delivery of taVNS for autism spectrum disorder: feasibility and initial efficacy.
Remotely supervised at-home delivery of taVNS for autism spectrum disorder: feasibility and initial efficacy.
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DOI：
10.3389/fpsyt.2023.1238328
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发表时间：
2023
影响因子：
4.7
通讯作者：
Beversdorf, David Q.
中科院分区：
文献类型：
--
作者：
Black, Benjamin;Hunter, Samantha;Cottrell, Hannah;Dar, Roee;Takahashi, Nicole;Ferguson, Bradley J.;Valter, Yishai;Porges, Eric;Datta, Abhishek;Beversdorf, David Q.
关键词：
经皮耳迷走神经刺激(TaVNS)对孤独症谱系障碍(ASD)有潜在的临床应用价值。居家会议是必要的，以允许重复会议，并减轻患者日常就诊的负担，并降低诊所交付的成本。我们的目标是验证使用专门设计的设备和平台对taVNS上门投递进行远程监督管理的协议。遵循开放标签设计，由照顾者给药给12名ASD患者(年龄：7-16岁)。每天1小时的疗程超过2 周，在远程监督下进行。主要结果是可行性，通过完成率、刺激耐受性和程序性刺激交付的确认来评估。采用儿童焦虑敏感指数修订版(CASI-R)、父母评定的青少年自闭症焦虑量表(PRAS-ASD)和临床医生总体印象量表(CGI)进行初步疗效评定。睡眠测量也使用克利夫兰青少年睡眠问卷(CASQ)进行跟踪。在132次会议上，我们获得了88.5%的完成率。总共报告了22个预期的不良事件，其中头痛是最常见的，其次是一过性疼痛、瘙痒和电极部位的刺痛。一名受试者退出了与刺激或研究无关的研究。在2 周的时间点，焦虑(CASI-R、PRAS-ASD和CGI)和嗜睡(CASQ)的平均得分均有所改善。虽然不能确定疗效，但在这项开放标签试验中提出了好处。在ASD患者中，远程监督、代理管理、在家交付taVNS是可行的。初步疗效支持进行更大规模的试验。
Transcutaneous auricular vagus nerve stimulation (taVNS) has potential clinical application for autism spectrum disorder (ASD). At-home sessions are necessary to allow delivery of repeated sessions, and remove burden on patients for daily visits, and reduce costs of clinic delivery. Our objective was to validate a protocol for remote supervised administration for home delivery of taVNS using specially designed equipment and platform. An open-label design was followed involving administration by caretakers to 12 patients with ASD (ages:7–16). Daily 1-h sessions over 2 weeks were administered under remote supervision. The primary outcome was feasibility, which was assessed by completion rate, stimulation tolerability, and confirmation of programmed stimulation delivery. The secondary measures were initial efficacy assessed by Childhood Anxiety Sensitivity Index-Revised (CASI-R), Parent Rated Anxiety Scale for Youth with ASD (PRAS-ASD), and Clinician Global Impression (CGI) scales. Sleep measures were also tracked using Cleveland Adolescent Sleep Questionnaire (CASQ). Across 132 sessions, we obtained an 88.5% completion rate. A total of 22 expected adverse events were reported with headache being the most common followed by transient pain, itchiness, and stinging at the electrode site. One subject dropped out of the study unrelated to the stimulation or the study. Average scores of anxiety (CASI-R, PRAS-ASD, and CGI) and sleepiness (CASQ) were all improved at the 2 week time point. While not powered to determine efficacy, benefits were suggested in this open label pilot. Remotely supervised, proxy-administered, at-home delivery of taVNS is feasible in patients with ASD. Initial efficacy supports pursuing larger scale trials.
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影响因子：
3
作者：
Charvet LE;Kasschau M;Datta A;Knotkova H;Stevens MC;Alonzo A;Loo C;Krull KR;Bikson M
通讯作者：
Bikson M
影响因子：
4.6
作者：
Kim, Angela Yun;Marduy, Anna;de Melo, Paulo S.;Gianlorenco, Anna Carolyna;Kim, Chi Kyung;Choi, Hyuk;Song, Jae-Jun;Fregni, Felipe
通讯作者：
Fregni, Felipe
影响因子：
3.3
作者：
Capone, Fioravante;Assenza, Giovanni;Di Lazzaro, Vincenzo
通讯作者：
Di Lazzaro, Vincenzo
影响因子：
2.8
作者：
Kasschau, Margaret;Reisner, Jesse;Charvet, Leigh E.
通讯作者：
Charvet, Leigh E.
DOI：
10.1097/dbp.0000000000000351
发表时间：
2016-10
期刊：
Journal of developmental and behavioral pediatrics : JDBP
影响因子：
--
作者：
Beversdorf DQ;MISSOURI AUTISM SUMMIT CONSORTIUM
通讯作者：
MISSOURI AUTISM SUMMIT CONSORTIUM