Xu Tingting, Gao Yuan, Li Bin, Jiang Jiaxin, Guo Huirong, Liu Xianzhi, Huang Hongxing, Cheng Yuqi, Yu Hualin, Hu Jie, Wu Xi, Wang Wei, Wang Zhen
Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai 200030, China.
West China Hospital, Sichuan University, Chengdu 610041, China.
Brain Sci. 2022 Jul 16;12(7):933. doi: 10.3390/brainsci12070933.
BACKGROUNDS: Deep brain stimulation (DBS) is an emerging and promising therapeutic approach for treatment-refractory obsessive-compulsive disorder (OCD). The most common DBS targets include the anterior limb of internal capsule (ALIC) and nucleus accumbens (NAcc). This protocol aims to explore the efficacy and safety of the combined ALIC- and NAcc-DBS for treatment-refractory OCD. METHODS: We will recruit 64 patients with refractory OCD from six centers, randomly allocate them to active and sham-stimulation groups through a three-month double-blind phase, then enter a three-month open-label phase. In the open-label stage, both groups experience real stimulation. OUTCOME MEASURES: The primary outcome will be the efficacy and safety of combined ALIC- and NAcc-DBS, determined by treatment response rate between the active and sham-stimulation groups at the double-blind stage and spontaneously reported adverse events. The secondary outcomes are comparisons of change in Y-BOCS, CGI, HAMD, and HAMA scores at the third and sixth months compared to baseline between the active and sham-control groups, as well as the scores of the third month minus the sixth month between the two groups.
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