Deep brain stimulation of Hippocampus in Treatment-resistant Schizophrenia (DBS-HITS): protocol for a crossover randomized controlled trial.

IF 3.4 2区医学 Q2 PSYCHIATRY

BMC Psychiatry Pub Date : 2024-11-25 DOI:10.1186/s12888-024-06318-6

Chang Lu, Zhaolin Zhai, Kaiming Zhuo, Qiong Xiang, Jingxin Xue, Yuqing Zhao, Liqin Lang, Chunhong Shao, Liang Chen, Dengtang Liu

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Abstract

Background: Ventral hippocampus (vHipp) in schizophrenia is in a state of hyperactivity and hypermetabolism, where the glutamate/gamma-aminobutyric acid (GABA) imbalance leads to downstream dopamine hyperactivity in the midbrain-limbic system. High-frequency deep brain stimulation (DBS) can disrupt the abnormal synchronization of functional circuits and modulate local brain networks.

Methods: The DBS-HITS study is a crossover randomized controlled trial. DBS will be applied to bilateral vHipp in six patients. They will be randomly assigned to receive 3-month high-frequency active stimulation and then 3-month sham stimulation, or vice versa. After 6-month crossover trial phase, all participants will undergo personalized active stimulation. Researchers will assess clinical symptoms and neurocognition, collect EEG and PET-CT data during planned follow-ups. Adverse event will be researcher-assessed or participant self-reported throughout the trial.

Discussion: To our knowledge, the DBS-HITS study is the first hippocampal DBS randomized controlled trial for schizophrenia. The goal of the DBS-HITS study is to assess the efficacy and safety of hippocampal DBS in treatment-resistant schizophrenia (TRS) and to investigate its impact on hippocampal activity and glutamate/GABA metabolism. The study is expected to deepen our understanding of the effects and side-effects of neuromodulation in TRS to facilitate individualized DBS treatment.

Trial registration: NCT05694000 in ClinicalTrial.gov, registered on January 23, 2023.

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海马体深部脑刺激治疗耐药精神分裂症（DBS-HITS）：交叉随机对照试验方案。

背景：精神分裂症患者的腹侧海马（vHipp）处于过度活跃和代谢亢进状态，谷氨酸/γ-氨基丁酸（GABA）失衡导致中脑-边缘系统下游多巴胺过度活跃。高频深部脑刺激（DBS）可以破坏功能回路的异常同步，调节局部脑网络：DBS-HITS研究是一项交叉随机对照试验。DBS-HITS 研究是一项交叉随机对照试验。他们将被随机分配接受为期 3 个月的高频主动刺激，然后再接受为期 3 个月的假刺激，反之亦然。6 个月的交叉试验阶段结束后，所有参与者都将接受个性化的主动刺激。研究人员将在计划的随访期间评估临床症状和神经认知，收集脑电图和 PET-CT 数据。在整个试验过程中，不良事件将由研究人员评估或参与者自我报告：据我们所知，DBS-HITS 研究是首个针对精神分裂症的海马 DBS 随机对照试验。DBS-HITS研究的目标是评估海马DBS治疗耐药精神分裂症（TRS）的疗效和安全性，并调查其对海马活动和谷氨酸/GABA代谢的影响。该研究有望加深我们对神经调控在 TRS 中的作用和副作用的理解，从而促进 DBS 治疗的个体化：试验注册：NCT05694000，ClinicalTrial.gov，注册日期：2023年1月23日。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

BMC Psychiatry 医学-精神病学

CiteScore

5.90

自引率

4.50%

发文量

716

审稿时长

3-6 weeks

期刊介绍： BMC Psychiatry is an open access, peer-reviewed journal that considers articles on all aspects of the prevention, diagnosis and management of psychiatric disorders, as well as related molecular genetics, pathophysiology, and epidemiology.