Zhou Hetong, Wang Minmin, Xu Ting, Zhang Xiaomei, Zhao Xudong, Tang Lili, Zhao Pengfei, Wang Dandan, Lai Jianbo, Wang Fei, Zhang Shaomin, Hu Shaohua
Department of Psychiatry, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Nanhu Brain-Computer Interface Institute, Hangzhou, China.
CNS Neurosci Ther. 2024 Dec;30(12):e70179. doi: 10.1111/cns.70179.
Non-invasive brain stimulation (NIBS), such as transcranial direct current stimulation (tDCS) and repetitive transcranial magnetic stimulation (rTMS), has emerged as a promising alternative in the precise treatment of clinical symptoms, such as the cognitive impairment of bipolar disorder (BD). Optimizing the neurocognitive effects by combining tDCS and rTMS to strengthen the clinical outcome is a challenging research issue.
In this randomized, controlled trial, we first combined tDCS and neuronavigated rTMS targeting the V1 region to explore the efficacy on neurocognitive function in BD patients with depressive episodes.
Eligible individuals (n = 105) were assigned into three groups, Group A (active tDCS-active rTMS), Group B (sham tDCS-active rTMS), and Group C (active tDCS-sham rTMS). All participants received 3-week treatment in which every participant received 15 sessions of stimulation through the study, 5 sessions every week, with tDCS treatment followed by neuronavigated rTMS every session. We evaluated the cognitive, emotional, and safety outcomes at week-0 (w0, baseline), week-3 (w3, immediately post-treatment), and week-8 (w8, follow-up period). The THINC-integrated tool (THINC-it), 17-item Hamilton Depression Rating Scale, and Young Mania Rating Scale were applied for evaluating the cognitive function and emotional state, respectively. Data were analyzed by repeated measure ANOVA and paired t-test.
Eventually, 32 patients in Group A, 27 in Group B, and 23 in Group C completed the entire treatment. Compared to Groups B and C, Group A showed greater improvement in Symbol Check items (Time and Accuracy) at W3 and Symbol Check Accuracy at W8 (p < 0.01). The W0-W3 analysis indicated a significant improvement in depressive symptoms in both Group A and Group B (p < 0.01). Additionally, neuroimaging data revealed increased activity in the calcarine sulcus in Group A, suggesting potential neuroplastic changes in the visual cortex following the electromagnetic stimulation.
These findings provide preliminary evidence that the combination of navigated rTMS with tDCS targeting V1 region may serve as a potential treatment strategy for improving cognitive impairment and depressive symptoms in BD patients.
Clinical Trial Registry number: NCT05596461.
非侵入性脑刺激（NIBS），如经颅直流电刺激（tDCS）和重复经颅磁刺激（rTMS），已成为精确治疗临床症状（如双相情感障碍（BD）的认知障碍）的一种有前景的替代方法。通过结合tDCS和rTMS来优化神经认知效应以增强临床疗效是一个具有挑战性的研究问题。
在这项随机对照试验中，我们首先将tDCS与靶向V1区域的神经导航rTMS相结合，以探索其对伴有抑郁发作的BD患者神经认知功能的疗效。
符合条件的个体（n = 105）被分为三组，A组（活性tDCS-活性rTMS）、B组（假tDCS-活性rTMS）和C组（活性tDCS-假rTMS）。所有参与者接受为期3周的治疗，在此期间，每位参与者在研究过程中接受15次刺激，每周5次，每次先进行tDCS治疗，然后进行神经导航rTMS。我们在第0周（w0，基线）、第3周（w3，治疗结束时）和第8周（w8，随访期）评估认知、情绪和安全性结果。分别应用THINC综合工具（THINC-it）、17项汉密尔顿抑郁量表和杨氏躁狂量表来评估认知功能和情绪状态。数据采用重复测量方差分析和配对t检验进行分析。
最终，A组32例患者、B组27例患者和C组23例患者完成了整个治疗。与B组和C组相比，A组在第3周的符号检查项目（时间和准确性）以及第8周的符号检查准确性方面有更大改善（p < 0.01）。第0周-第3周的分析表明，A组和B组的抑郁症状均有显著改善（p < 0.01）。此外，神经影像学数据显示A组距状沟的活动增加，表明电磁刺激后视觉皮层可能发生了神经可塑性变化。
这些发现提供了初步证据，表明将神经导航rTMS与靶向V1区域的tDCS相结合可能是改善BD患者认知障碍和抑郁症状的一种潜在治疗策略。
临床试验注册号：NCT05596461。
