Shanghai Mental Health Center, 200030, Shanghai, China.
Department of Psychiatry, Huashan Hospital Fudan University, 200040, Shanghai, China.
BMC Psychiatry. 2024 Nov 25;24(1):847. doi: 10.1186/s12888-024-06318-6.
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.
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.
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.
NCT05694000 in ClinicalTrial.gov, registered on January 23, 2023.
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，其中谷氨酸/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，并调节局部脑网络。
DBS-HITS 研究是一项交叉随机对照试验。DBS 将应用于六名患者的双侧 vHipp。他们将被随机分配接受 3 个月的高频激活刺激，然后是 3 个月的假刺激，或者反之亦然。经过 6 个月的交叉试验阶段后，所有参与者将接受个性化的主动刺激。研究人员将在计划的随访中评估临床症状和神经认知，收集 EEG 和 PET-CT 数据。整个试验过程中，将由研究人员评估或由参与者自行报告不良事件。
据我们所知，DBS-HITS 研究是第一项针对精神分裂症的海马 DBS 随机对照试验。DBS-HITS 研究的目的是评估海马 DBS 在治疗抵抗性精神分裂症（TRS）中的疗效和安全性，并研究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 TRS 中神经调节作用和副作用的理解，以促进个体化 DBS 治疗。
NCT05694000 在 ClinicalTrials.gov 注册，注册日期为 2023 年 1 月 23 日。
