Sreeraj Vanteemar S, Goyal Nishant, Shenoy Sonia, Balachander Srinivas, Arumugham Shyam Sundar, Parlikar Rujuta, Bagali Kiran Basawaraj, Chithra Uppinkudru, Sinha Preeti, Purohith Abhiram Narasimhan, Roy Chandramouli, Shivakumar Venkataram, Udupa Kaviraja, Thennarasu Kandavel, Shreekantiah Umesh, Praharaj Samir K, Muralidharan Kesavan, Thirthalli Jagadisha, Mehta Urvakhsh Meherwan, Venkatasubramanian Ganesan
Department of Psychiatry, National Institute of Mental Health and Neuro Sciences, Bengaluru, Karnataka, 560029, India.
Department of Psychiatry, Central Institute of Psychiatry, Ranchi, Jharkhand, 834006, India.
Wellcome Open Res. 2025 Feb 12;9:137. doi: 10.12688/wellcomeopenres.20956.2. eCollection 2024.
Schizophrenia is one of the most burdensome psychiatric disorders. Novel neuromodulatory techniques including cathodal transcranial direct current stimulation (c-tDCS) and continuous theta burst stimulation (cTBS) using repetitive transcranial magnetic stimulation (rTMS) are increasingly being used in alleviating the auditory verbal hallucinations that are persisting despite adequate antipsychotic treatment. Brain connectivity modulation by stimulating the left temporoparietal junction is thought to mediate these effects. The differential neurobiological mechanisms and efficacy of these two neuromodulation techniques are not known. We are unaware of any systematic studies that can guide clinicians in choosing between the two techniques. This protocol describes a parallel-arm, double-blind, randomized cross-over study to identify resting brain functional connectivity markers of response to cTBS and c-tDCS persistent auditory hallucinations to improve the efficacy of interventions.
Two hundred and ten consenting patients with schizophrenia with persistent auditory hallucinations will be randomly assigned to receive 15 days (30 sessions) of c-tDCS+sham-TBS or sham-tDCS+cTBS over the left temporoparietal region at three study centres. After a gap of 2-4 weeks, non-responders to the intervention will cross-over to the other arm. Clinical assessments, neurocognitive assessments, and multimodal investigations (magnetic resonance imaging, electroencephalography, heart rate variability, investigative transcranial magnetic stimulation-transcranial direct current stimulation, gene polymorphisms) will be conducted at baseline and repeated after the end of both phases of the trial. A differential pre-treatment resting brain functional connectivity signal will identify responders to cTBS or c-tDCS.
Clinical Trial Registry of India ( CTRI/2021/05/033783) registered on 25/05/2021.
精神分裂症是最具负担的精神疾病之一。包括阴极经颅直流电刺激（c-tDCS）和使用重复经颅磁刺激（rTMS）的连续theta爆发刺激（cTBS）在内的新型神经调节技术越来越多地用于缓解尽管接受了充分的抗精神病药物治疗但仍持续存在的幻听症状。通过刺激左侧颞顶联合区调节大脑连接性被认为可介导这些效应。这两种神经调节技术的不同神经生物学机制和疗效尚不清楚。我们不知道有任何系统性研究可以指导临床医生在这两种技术之间进行选择。本方案描述了一项平行组、双盲、随机交叉研究，以确定对cTBS和c-tDCS治疗持续性幻听反应的静息脑功能连接标记物，以提高干预效果。
210名患有持续性幻听的精神分裂症同意患者将被随机分配到三个研究中心，在左侧颞顶区接受15天（30次）的c-tDCS+假TBS或假tDCS+cTBS治疗。在间隔2-4周后，对干预无反应者将交叉至另一组。将在基线时进行临床评估、神经认知评估和多模态检查（磁共振成像、脑电图、心率变异性、经颅磁刺激-经颅直流电刺激研究、基因多态性），并在试验的两个阶段结束后重复进行。治疗前静息脑功能连接信号的差异将识别出对cTBS或c-tDCS有反应者。
于2021年5月25日在印度临床试验注册中心（CTRI/2021/05/033783）注册。
