Wang Shuzhe, Chen Junhao, Wang Linxuan, Liu Jingxuan, Wang Lijun, Sun Wenjie, Li Shen, Li Jie
Mental Health Center of Tianjin University, Tianjin Anding Hospital, Tianjin, 300222, China.
Brain Assessment & Intervention Laboratory, Tianjin Anding Hospital, Mental Health Center of Tianjin Medical University, Tianjin, 300222, China.
BMC Psychiatry. 2025 Jul 18;25(1):714. doi: 10.1186/s12888-025-07158-8.
Cognitive deficits and negative symptoms are core features of schizophrenia (SCZ) and remain major therapeutic challenges due to their limited responsiveness to antipsychotic medications. Transcranial temporal interference stimulation (tTIS) is a novel, non-invasive brain stimulation technique that enables targeted modulation of deep brain structures with high spatial specificity. While tTIS has shown promise in preliminary studies of other neuropsychiatric conditions, its clinical utility in SCZ has not been established. This study aims to evaluate the safety and efficacy of tTIS targeting the right nucleus accumbens (NAc) in ameliorating cognitive deficits and negative symptoms in SCZ individuals.
In this randomized, double-blind, controlled trial, 76 SCZ patients with prominent cognitive deficits and negative symptoms will be recruited and randomly assigned to receive either active or sham tTIS. All participants will maintain stable antipsychotic regimens for at least 30 days prior to and throughout the intervention. The tTIS protocol comprises ten 30-min weekday stimulation sessions. Outcome assessments will be conducted at four time points: baseline (T0), post-intervention (T1), two weeks (T2), and four weeks (T3) after the final sesseion. The primary outcome is the change in cognitive performance, measured by the MATRICS Consensus Cognitive Battery (MCCB). Secondary outcomes include changes in positive and negative symptoms, depressive and anxiety symptoms, sleep quality, quality of life, and resting-state functional magnetic resonance imaging (rs-fMRI) parameters.
This trial will provide the first randomized controlled evidence on the clinical efficacy and neural effects of tTIS in SCZ patients. We hypothesize that participants receiving active tTIS will demonstrate significantly greater improvements in cognitive function and negative symptoms compared to those receiving sham stimulation.
Chinese Clinical Trial Registry (ChiCTR2500102724). Recruitment is scheduled to begin on May 27, 2025.
认知缺陷和阴性症状是精神分裂症（SCZ）的核心特征，由于它们对抗精神病药物的反应有限，仍然是主要的治疗挑战。经颅颞干扰刺激（tTIS）是一种新型的非侵入性脑刺激技术，能够以高空间特异性对深部脑结构进行靶向调节。虽然tTIS在其他神经精神疾病的初步研究中显示出前景，但其在SCZ中的临床效用尚未确立。本研究旨在评估靶向右侧伏隔核（NAc）的tTIS改善SCZ患者认知缺陷和阴性症状的安全性和有效性。
在这项随机、双盲、对照试验中，将招募76名有明显认知缺陷和阴性症状的SCZ患者，并随机分配接受主动或假tTIS。所有参与者在干预前至少30天及整个干预过程中都将维持稳定的抗精神病药物治疗方案。tTIS方案包括十个工作日的30分钟刺激疗程。结果评估将在四个时间点进行：基线（T0）、干预后（T1）、最后一次疗程后两周（T2）和四周（T3）。主要结果是通过MATRICS共识认知电池（MCCB）测量的认知表现变化。次要结果包括阳性和阴性症状、抑郁和焦虑症状、睡眠质量、生活质量以及静息态功能磁共振成像（rs-fMRI）参数的变化。
本试验将提供关于tTIS在SCZ患者中的临床疗效和神经效应的首个随机对照证据。我们假设，与接受假刺激的参与者相比，接受主动tTIS的参与者在认知功能和阴性症状方面将有显著更大的改善。
中国临床试验注册中心（ChiCTR2500102724）。招募计划于2025年5月27日开始。
