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

Autor: Lu C; Shanghai Mental Health Center, 200030, Shanghai, China.; Department of Psychiatry, Huashan Hospital Fudan University, 200040, Shanghai, China., Zhai Z; Shanghai Mental Health Center, 200030, Shanghai, China.; Department of Psychiatry, Huashan Hospital Fudan University, 200040, Shanghai, China., Zhuo K; Shanghai Mental Health Center, 200030, Shanghai, China., Xiang Q; Shanghai Mental Health Center, 200030, Shanghai, China., Xue J; Shanghai Mental Health Center, 200030, Shanghai, China.; Department of Psychiatry, Huashan Hospital Fudan University, 200040, Shanghai, China., Zhao Y; Shanghai Mental Health Center, 200030, Shanghai, China.; Department of Psychiatry, Huashan Hospital Fudan University, 200040, Shanghai, China., Lang L; Department of Neurosurgery, Huashan Hospital Fudan University, 200040, Shanghai, China., Shao C; Department of Psychiatry, Huashan Hospital Fudan University, 200040, Shanghai, China., Chen L; Department of Neurosurgery, Huashan Hospital Fudan University, 200040, Shanghai, China., Liu D; Shanghai Mental Health Center, 200030, Shanghai, China. liudengtang@smhc.org.cn.; Department of Psychiatry, Huashan Hospital Fudan University, 200040, Shanghai, China. liudengtang@smhc.org.cn.
Jazyk: angličtina
Zdroj: BMC psychiatry [BMC Psychiatry] 2024 Nov 25; Vol. 24 (1), pp. 847. Date of Electronic Publication: 2024 Nov 25.
DOI: 10.1186/s12888-024-06318-6
Abstrakt: 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.
Competing Interests: Declarations. Ethics approval and consent to participate: Ethical approval for the study was granted by the ethics committee at Shanghai Mental Health Center in October 2022 (approval letter number: 2022-70) and by Huashan Hospital Institutional Review Board (HIRB), Fudan University in June 2023 (approval letter number: 2022 − 949). Written informed consent will be obtained from all participants before entering the DBS-HITS project. Consent for publication: Not applicable. Competing interests: The authors declare no competing interests.
(© 2024. The Author(s).)
Databáze: MEDLINE
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