采用新型弥散张量成像（DTI）引导的多模态神经刺激方案减轻双相情感障碍的认知障碍：一项双盲随机对照试验
Alleviating cognitive impairments in bipolar disorder with a novel DTI-guided multimodal neurostimulation protocol: a double-blind randomized controlled trial.
作者信息
Wang Minmin, Zhou Hetong, Zhang Xiaomei, Chen Qianfeng, Tong Qiqi, Han Qiai, Zhao Xudong, Wang Dandan, Lai Jianbo, He Hongjian, Zhang Shaomin, Hu Shaohua
机构信息
Department of Psychiatry, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Westlake Institute for Optoelectronics, Westlake University, Hangzhou, China.
出版信息
BMC Med. 2025 Jun 4;23(1):334. doi: 10.1186/s12916-025-04174-z.
BACKGROUND
Traditional neuromodulation strategies show promise in enhancing cognitive abilities in bipolar disorder (BD) but remain suboptimal. This study introduces a novel multimodal neurostimulation (MNS) protocol to improve therapeutic outcomes.
METHODS
The novel MNS protocol used individualized diffusion tensor imaging (DTI) data to identify fiber tracts between the dorsolateral prefrontal cortex and dorsal anterior cingulate cortex. The highest structural connectivity point is selected as the individualized stimulation site, which is then targeted using a combination of optimized transcranial alternating current stimulation (tACS) and robot-assisted navigated repetitive transcranial magnetic stimulation (rTMS). A double-blind randomized controlled trial was conducted to investigate the clinical efficacy of this innovative neuromodulation approach on cognitive abilities in stable-phase BD patients. One hundred BD patients were randomly assigned to four groups: group A (active tACS-active rTMS (MNS protocol)), group B (sham tACS-active rTMS), group C (active tACS-sham rTMS), and group D (sham tACS-sham rTMS). Participants underwent 15 sessions over 3 weeks. Cognitive assessments (THINC integrated tool) were conducted at baseline (week 0) and post-treatment (week 3).
RESULTS
Sixty-six participants completed all 15 sessions. Group A (MNS protocol) showed superior improvements in Spotter CRT, TMT, and DSST scores compared to other groups at week 3. Only group A exhibited significant activation in the left frontal region post-MNS intervention. The novel MNS protocol was well tolerated, with no significant side effects observed.
CONCLUSIONS
The study indicates that DTI-guided multimodal neurostimulation mode significantly improves cognitive impairments and is safe for stable-phase BD patients.
TRIAL REGISTRATION
ClinicalTrials.gov identifier: NCT05964777.
背景
传统的神经调节策略在增强双相情感障碍（BD）患者的认知能力方面显示出前景，但仍未达到最佳效果。本研究引入了一种新型多模态神经刺激（MNS）方案以改善治疗效果。
方法
新型MNS方案使用个体化弥散张量成像（DTI）数据来识别背外侧前额叶皮层与背侧前扣带回皮层之间的纤维束。选择结构连接性最高的点作为个体化刺激部位，然后使用优化的经颅交流电刺激（tACS）和机器人辅助导航重复经颅磁刺激（rTMS）相结合的方法对其进行靶向刺激。进行了一项双盲随机对照试验，以研究这种创新的神经调节方法对稳定期BD患者认知能力的临床疗效。100名BD患者被随机分为四组：A组（主动tACS-主动rTMS（MNS方案））、B组（假tACS-主动rTMS）、C组（主动tACS-假rTMS）和D组（假tACS-假rTMS）。参与者在3周内接受15次治疗。在基线（第0周）和治疗后（第3周）进行认知评估（THINC综合工具）。
结果
66名参与者完成了全部15次治疗。在第3周时，A组（MNS方案）在Spotter CRT、TMT和DSST评分方面的改善优于其他组。仅A组在MNS干预后左侧额叶区域表现出显著激活。新型MNS方案耐受性良好，未观察到明显副作用。
结论
该研究表明，DTI引导的多模态神经刺激模式可显著改善认知障碍，且对稳定期BD患者是安全的。
试验注册
ClinicalTrials.gov标识符：NCT05964777。
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