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虚拟现实与经颅直流电刺激治疗创伤后应激障碍的随机临床试验

Virtual Reality and Transcranial Direct Current Stimulation for Posttraumatic Stress Disorder: A Randomized Clinical Trial.

机构信息

Center for Neurorestoration and Neurotechnology, VA Providence Healthcare System, Providence, Rhode Island.

Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, Rhode Island.

出版信息

JAMA Psychiatry. 2024 May 1;81(5):437-446. doi: 10.1001/jamapsychiatry.2023.5661.

Abstract

IMPORTANCE

Posttraumatic stress disorder (PTSD) is a common psychiatric disorder that is particularly difficult to treat in military veterans. Noninvasive brain stimulation has significant potential as a novel treatment to reduce PTSD symptoms.

OBJECTIVE

To test whether active transcranial direct current stimulation (tDCS) plus virtual reality (VR) is superior to sham tDCS plus VR for warzone-related PTSD.

DESIGN, SETTING, AND PARTICIPANTS: This double-blind randomized clinical trial was conducted among US military veterans enrolled from April 2018 to May 2023 at a secondary care Department of Veterans Affairs hospital and included 1- and 3-month follow-up visits. Participants included US military veterans with chronic PTSD and warzone-related exposure, recruited via referral and advertisement. Patients in psychiatric treatment had to be on a stable regimen for at least 6 weeks to be eligible for enrollment. Data were analyzed from May to September 2023.

INTERVENTION

Participants were randomly assigned to receive 2-mA anodal tDCS or sham tDCS targeted to the ventromedial prefrontal cortex, during six 25-minute sessions of standardized warzone VR exposure, delivered over 2 to 3 weeks.

MAIN OUTCOMES AND MEASURES

The co-primary outcomes were self-reported PTSD symptoms, measured via the PTSD checklist for DSM-5 (PCL-5), alongside quality of life. Other outcomes included psychophysiological arousal, clinician-assessed PTSD, depression, and social/occupational function.

RESULTS

A total of 54 participants (mean [SD] age, 45.7 [10.5] years; 51 [94%] males) were assessed, including 26 in the active tDCS group and 28 in the sham tDCS group. Participants in the active tDCS group reported a superior reduction in self-reported PTSD symptom severity at 1 month (t = -2.27, P = .02; Cohen d = -0.82). There were no significant differences in quality of life between active and sham tDCS groups. Active tDCS significantly accelerated psychophysiological habituation to VR events between sessions compared with sham tDCS (F5,7689.8 = 4.65; P < .001). Adverse effects were consistent with the known safety profile of the corresponding interventions.

CONCLUSIONS AND RELEVANCE

These findings suggest that combined tDCS plus VR may be a promising strategy for PTSD reduction and underscore the innovative potential of these combined technologies.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT03372460.

摘要

重要性

创伤后应激障碍(PTSD)是一种常见的精神疾病,尤其在退伍军人中难以治疗。非侵入性脑刺激具有作为一种新的治疗方法来减轻 PTSD 症状的巨大潜力。

目的

测试主动经颅直流电刺激(tDCS)加虚拟现实(VR)是否优于假 tDCS 加 VR 治疗战区相关 PTSD。

设计、设置和参与者:这项双盲随机临床试验于 2018 年 4 月至 2023 年 5 月在美国退伍军人事务部二级保健医院进行,包括 1 个月和 3 个月的随访。参与者包括通过转介和广告招募的有慢性 PTSD 和战区暴露史的美国退伍军人。接受精神科治疗的患者必须至少有 6 周的稳定治疗方案才能有资格参加。数据于 2023 年 5 月至 9 月进行分析。

干预

参与者被随机分配接受 2 mA 阳极 tDCS 或假 tDCS,目标是腹内侧前额叶皮质,在 2 到 3 周内进行六次 25 分钟的标准化战区 VR 暴露。

主要结果和措施

共同的主要结果是自我报告的 PTSD 症状,通过 DSM-5 PTSD 检查表(PCL-5)测量,以及生活质量。其他结果包括心理生理唤醒、临床评估的 PTSD、抑郁和社会/职业功能。

结果

共评估了 54 名参与者(平均[标准差]年龄 45.7[10.5]岁;51[94%]男性),其中 26 名在主动 tDCS 组,28 名在假 tDCS 组。主动 tDCS 组在 1 个月时报告 PTSD 症状严重程度显著降低(t=-2.27,P=.02;Cohen d=-0.82)。主动 tDCS 组和假 tDCS 组在生活质量方面无显著差异。与假 tDCS 相比,主动 tDCS 显著加速了各次治疗之间 VR 事件的心理生理习惯化(F5,7689.8=4.65;P<.001)。不良事件与相应干预措施的已知安全性特征一致。

结论和相关性

这些发现表明,tDCS 加 VR 联合治疗可能是减轻 PTSD 的一种有前途的策略,并强调了这些联合技术的创新性潜力。

试验注册

ClinicalTrials.gov 标识符:NCT03372460。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9fef/10918574/a3562a5a370d/jamapsychiatry-e235661-g001.jpg

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