The Efficacy and Safety of Deep Brain Stimulation of Combined Anterior Limb of Internal Capsule and Nucleus Accumbens (ALIC/NAcc-DBS) for Treatment-Refractory Obsessive-Compulsive Disorder: Protocol of a Multicenter, Randomized, and Double-Blinded Study
机构:[1]Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai 200030, China.[2]West China Hospital, Sichuan University, Chengdu 610041, China.四川大学华西医院[3]The First Affiliated Hospital of Zhengzhou University, Zhengzhou University, Zhengzhou 450052, China.[4]Brains Hospital of Hunan Province, Changsha 410015, China.[5]First Affiliated Hospital of Kunming Medical University, Kunming 650031, China.昆明医科大学附属第一医院[6]Huashan Hospital, Fudan University, Shanghai 200040, China.[7]Changhai Hospital, The Navy Military Medical University, Shanghai 200086, China.
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.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.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.
基金:
Shanghai Science and Technology Committee (Grant
Number: 20XD1423100) and Shanghai Clinical Research Center for Mental Health (Grant Number:
19MC1911100).
第一作者机构:[1]Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai 200030, China.
共同第一作者:
通讯作者:
推荐引用方式(GB/T 7714):
Xu Tingting,Gao Yuan,Li Bin,et al.The Efficacy and Safety of Deep Brain Stimulation of Combined Anterior Limb of Internal Capsule and Nucleus Accumbens (ALIC/NAcc-DBS) for Treatment-Refractory Obsessive-Compulsive Disorder: Protocol of a Multicenter, Randomized, and Double-Blinded Study[J].BRAIN SCIENCES.2022,12(7):doi:10.3390/brainsci12070933.
APA:
Xu Tingting,Gao Yuan,Li Bin,Jiang Jiaxin,Guo Huirong...&Wang Zhen.(2022).The Efficacy and Safety of Deep Brain Stimulation of Combined Anterior Limb of Internal Capsule and Nucleus Accumbens (ALIC/NAcc-DBS) for Treatment-Refractory Obsessive-Compulsive Disorder: Protocol of a Multicenter, Randomized, and Double-Blinded Study.BRAIN SCIENCES,12,(7)
MLA:
Xu Tingting,et al."The Efficacy and Safety of Deep Brain Stimulation of Combined Anterior Limb of Internal Capsule and Nucleus Accumbens (ALIC/NAcc-DBS) for Treatment-Refractory Obsessive-Compulsive Disorder: Protocol of a Multicenter, Randomized, and Double-Blinded Study".BRAIN SCIENCES 12..7(2022)