Trials · 2024
Safety and effectiveness of transcutaneous auricular vagus nerve stimulation on patients with depersonalization-derealization disorder: study protocol for a randomized controlled trial.
Протокол клинического исследованияСтатьяНазвание и аннотация: Перевод пока не подготовлен
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Zhao Yan, Zheng Sisi, Zhu Hong, Yin Dongqing, Fang Meng, Jia Hongxiao
Аннотация
BACKGROUND: Depersonalization-derealization disorder (DPD) is a complex psychiatric condition marked by profound and often relentless feelings of detachment from one's self and surroundings. Transcranial electrical stimulation (taVNS) holds promise as a potential therapeutic approach for DPD. This study aims to investigate the safety and efficacy of taVNS in treating DPD.
METHODS: DPD patients were recruited as research subjects and randomly allocated to the experimental and control groups, with the former receiving active-taVNS treatment and the latter receiving sham stimulation treatment for 6 weeks. The efficacy of taVNS in treating DPD was evaluated by comparing scores for DPD symptoms, depression and anxiety symptoms, cognitive function, and social function before and after treatment between the two groups. The safety of taVNS in treating DPD was assessed by comparing general safety assessment results between the two groups of DPD patients.
DISCUSSION: This study will assess taVNS as a potential treatment for DPD, evaluating its safety, efficacy, and impact on patient outcomes and societal burden.
TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR2300078183, Registered on 30 November, 2023, https://www.chictr.org.cn/showproj.html?proj=206119.
METHODS: DPD patients were recruited as research subjects and randomly allocated to the experimental and control groups, with the former receiving active-taVNS treatment and the latter receiving sham stimulation treatment for 6 weeks. The efficacy of taVNS in treating DPD was evaluated by comparing scores for DPD symptoms, depression and anxiety symptoms, cognitive function, and social function before and after treatment between the two groups. The safety of taVNS in treating DPD was assessed by comparing general safety assessment results between the two groups of DPD patients.
DISCUSSION: This study will assess taVNS as a potential treatment for DPD, evaluating its safety, efficacy, and impact on patient outcomes and societal burden.
TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR2300078183, Registered on 30 November, 2023, https://www.chictr.org.cn/showproj.html?proj=206119.