靶向背侧前扣带皮层的经颅时间干涉刺激治疗精神分裂症阴性症状与认知障碍：受试者与评估者盲法假对照随机对照试验方案
Dorsal anterior cingulate cortex-targeted transcranial temporal interference stimulation for negative symptoms and cognitive impairment in schizophrenia: a participant- and assessor-blinded, sham-controlled randomized controlled trial protocol
精神分裂症的持续性阴性症状（如情感淡漠、动力缺乏）和认知缺陷是功能恢复的主要障碍，药物和心理干预效果有限，常用无创脑刺激又难以作用于深部皮层。经颅时间干涉刺激（tTIS，通过多路电流干涉在深部脑区形成刺激焦点）是新兴技术。该方案拟纳入74例患者，随机接受真刺激或假刺激，2周内完成10次、每次30分钟，主要终点为背侧前扣带皮层（dACC）靶向刺激后阴性症状量表评分变化。这是研究方案，结果将指导未来深部无创刺激研究设计。
为什么推荐给您：tTIS深部靶向治疗精神分裂症是新方向，但仅为试验方案，尚无疗效数据
不需要生物学背景，多打比方
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摘要Abstract
BACKGROUND: Persistent negative symptoms and cognitive deficits remain major obstacles to functional recovery in schizophrenia. These impairments are often only partially responsive to antipsychotic treatment and may persist even when other symptoms are clinically stable. Psychosocial interventions show inconsistent efficacy, and commonly used non-invasive brain stimulation techniques have limited ability to target deeper cortical regions. Transcranial temporal interference stimulation (tTIS) has recently emerged as a promising approach for modulating neural activity in such regions. This trial aims to evaluate the clinical efficacy of tTIS targeting the dorsal anterior cingulate cortex (dACC) in individuals with schizophrenia.
METHODS: Seventy-four participants with schizophrenia will be enrolled in a parallel-group, sham-controlled trial. After random allocation, half of the participants will receive active stimulation and the remainder will receive sham stimulation. Group assignment will be blinded from participants and clinical evaluators. Each participant will complete 10 sessions over 2 weeks, with one 30-minute session scheduled on each weekday. Assessments will be completed before the first session, after the treatment course, and 4 weeks after treatment completion. Evaluation will include symptom ratings, neuropsychological testing, behavioral tasks, and multimodal neuroimaging. The primary endpoint is the baseline-adjusted between-group difference in the Positive and Negative Syndrome Scale negative symptom subscale (PANSS-NS) score at T1. The PANSS-NS score at T2 will be analyzed as a secondary outcome to evaluate the durability of the treatment effect. The Brief Assessment of Cognition in Schizophrenia composite z-score and the Scale for the Assessment of Negative Symptoms total score are prespecified as key secondary outcomes. Participants will be included in the primary analysis according to their original treatment assignment.
DISCUSSION: This study aims to determine whether dACC-targeted tTIS is feasible and clinically promising in schizophrenia. By combining symptom evaluation with cognitive, behavioral, and imaging measures, the trial may also generate preliminary evidence about treatment-related neural changes. The results will help guide the design of future studies evaluating deep-targeted non-invasive stimulation in psychiatric populations.
CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov/, identifier NCT07658898.