Efficacy and mechanisms underlying MRI-guided high-definition transcranial direct current stimulation for depression among university students: study protocol for a stepped wedge cluster randomized controlled trial.

IF 3.4 2区 医学 Q2 PSYCHIATRY
Yuanle Chen, Rongxun Liu, Jinnan Yan, Peng Luo, Luhan Yang, Yongbin Wang, Guangjun Ji, Chuansheng Wang, Wei Zheng, Fei Wang, Yong Meng, Yange Wei
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引用次数: 0

Abstract

Background: In worldwide, the prevalence of depression among university students raises year by year. Although current interventions for depression may be effective, only about one-third experiencing complete response. There is a critical need for more effective, precision, and personalized approaches for depression. High-definition transcranial direct current stimulation (HD-tDCS) shows promise as a potential intervention in depression, yet its optimal stimulation parameters and neural mechanisms remain unclear. In this study, we aim to evaluate the effectiveness of magnetic resonance imaging (MRI)-guided HD-tDCS in depression among university students and explore its neural mechanisms.

Method: In this stepped-wedge cluster randomized controlled trial, all participants will be randomly assigned to four groups. During the intervention, all groups will receive sham stimulation at week 1. With each subsequent week, one group will transition to active intervention. All groups will be receiving active intervention in week 5. Structural MRI data for each participant will be acquired to select the optimal electrode placement and correct for individual anatomical differences. The central anodal electrode will be positioned over the left dorsolateral prefrontal cortex (DLPFC), and four return electrodes will be placed 3.5 cm from the central electrode to form a circular current loop. The HD-tDCS will be delivered at a current intensity of 2 mA for 30 min per day, 5 days per week. Psychological assessment will conduct at week 0 (baseline), 1-5, and 9. MRI measurements will be performed before and after HD-tDCS. The primary outcome measures are changes in the Hamilton Rating Scale for Depression (HAMD) and Patient Health Questionnaire-9 (PHQ-9). Secondary outcomes are severity of anxiety, insomnia, and stress. Furthermore, we will employ functional near-infrared spectroscopy (fNIRS) and MRI to explore the neural mechanisms underlying the effects of HD-tDCS on depression.

Discussion: This study will facilitate the development of precision interventions for depression at an individual level. Multi-modal imaging approaches will provide a deepened insight into the role of MRI-guided HD-tDCS in depression and may ultimately improve intervention strategies among university students.

Trial registration: This study is registered in https://www.chictr.org.cn/ under protocol registration number ChiCTR2400094235 (date of registration: 19. December. 2024). Recruitment will start in March 2025.

mri引导下高清晰度经颅直流电刺激治疗大学生抑郁症的疗效和机制:阶梯形聚类随机对照试验的研究方案
背景:在世界范围内,大学生抑郁症的患病率呈逐年上升趋势。虽然目前对抑郁症的干预措施可能有效,但只有大约三分之一的人有完全的反应。我们迫切需要更有效、更精确、更个性化的方法来治疗抑郁症。高分辨率经颅直流电刺激(HD-tDCS)有望成为抑郁症的潜在干预手段,但其最佳刺激参数和神经机制尚不清楚。在本研究中,我们旨在评估磁共振成像(MRI)引导下HD-tDCS在大学生抑郁症中的有效性,并探讨其神经机制。方法:采用楔形步进式随机对照试验,将所有受试者随机分为4组。干预期间,各组在第1周接受假刺激。随后的每一周,一组将过渡到积极干预。所有组在第5周接受积极干预。将获取每个参与者的结构MRI数据,以选择最佳电极位置并纠正个体解剖差异。中心阳极电极将放置在左背外侧前额叶皮层(DLPFC)上方,四个返回电极将放置在距离中心电极3.5厘米处,形成一个圆形电流回路。HD-tDCS将以2 mA的电流强度交付,每天30分钟,每周5天。心理评估将在第0周(基线)、1-5周和第9周进行。在HD-tDCS前后分别进行MRI测量。主要结果测量是汉密尔顿抑郁评定量表(HAMD)和患者健康问卷-9 (PHQ-9)的变化。次要结果是焦虑、失眠和压力的严重程度。此外,我们将利用功能近红外光谱(fNIRS)和MRI来探讨HD-tDCS对抑郁症影响的神经机制。讨论:本研究将促进在个体水平上对抑郁症进行精确干预的发展。多模态成像方法将为mri引导的HD-tDCS在抑郁症中的作用提供深入的见解,并可能最终改善大学生的干预策略。试验注册:本研究在https://www.chictr.org.cn/注册,方案注册号为ChiCTR2400094235(注册日期:19)。2024年12月。)。招聘将于2025年3月开始。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
BMC Psychiatry
BMC Psychiatry 医学-精神病学
CiteScore
5.90
自引率
4.50%
发文量
716
审稿时长
3-6 weeks
期刊介绍: BMC Psychiatry is an open access, peer-reviewed journal that considers articles on all aspects of the prevention, diagnosis and management of psychiatric disorders, as well as related molecular genetics, pathophysiology, and epidemiology.
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