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

Autor: Chang Lu, Zhaolin Zhai, Kaiming Zhuo, Qiong Xiang, Jingxin Xue, Yuqing Zhao, Liqin Lang, Chunhong Shao, Liang Chen, Dengtang Liu
Jazyk: angličtina
Rok vydání: 2024
Předmět:
Zdroj: BMC Psychiatry, Vol 24, Iss 1, Pp 1-8 (2024)
Druh dokumentu: article
ISSN: 1471-244X
DOI: 10.1186/s12888-024-06318-6
Popis: 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.
Databáze: Directory of Open Access Journals
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