Chen Yuanle, Liu Rongxun, Yan Jinnan, Luo Peng, Yang Luhan, Wang Yongbin, Ji Guangjun, Wang Chuansheng, Zheng Wei, Wang Fei, Meng Yong, Wei Yange
Department of Early Intervention, Mental Health and Artificial Intelligence Research Center, The Second Affiliated Hospital of Xinxiang Medical University, Henan Mental Hospital, 207 Qianjin Road, Xinxiang, 453002, China.
School of Psychology, Xinxiang Medical University, Xinxiang, 453003, China.
BMC Psychiatry. 2025 Jul 1;25(1):630. doi: 10.1186/s12888-025-07118-2.
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.
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.
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.
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.
在全球范围内，大学生抑郁症的患病率逐年上升。尽管目前针对抑郁症的干预措施可能有效，但只有约三分之一的患者能实现完全缓解。迫切需要更有效、精准和个性化的抑郁症治疗方法。高清经颅直流电刺激（HD-tDCS）显示出作为抑郁症潜在干预手段的前景，但其最佳刺激参数和神经机制仍不清楚。在本研究中，我们旨在评估磁共振成像（MRI）引导下的HD-tDCS对大学生抑郁症的疗效，并探索其神经机制。
在这项阶梯式楔形整群随机对照试验中，所有参与者将被随机分为四组。在干预期间，所有组在第1周将接受假刺激。在随后的每周，一组将过渡到主动干预。所有组在第5周将接受主动干预。将获取每位参与者的结构MRI数据，以选择最佳电极放置位置并校正个体解剖差异。中央阳电极将置于左侧背外侧前额叶皮质（DLPFC）上方，四个返回电极将放置在距中央电极3.5厘米处，以形成环形电流回路。HD-tDCS将以2毫安的电流强度每天输送30分钟，每周5天。将在第0周（基线）、第1 - 5周和第9周进行心理评估。将在HD-tDCS前后进行MRI测量。主要结局指标是汉密尔顿抑郁量表（HAMD）和患者健康问卷-9（PHQ-9）的变化。次要结局是焦虑、失眠和压力的严重程度。此外，我们将采用功能近红外光谱（fNIRS）和MRI来探索HD-tDCS对抑郁症影响的神经机制。
本研究将促进个体层面抑郁症精准干预措施的发展。多模态成像方法将更深入地了解MRI引导下的HD-tDCS在抑郁症中的作用，并最终可能改善大学生的干预策略。
本研究已在https://www.chictr.org.cn/注册，注册号为ChiCTR2400094235（注册日期：2024年12月19日）。招募将于2025年3月开始。
