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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.

Tingting XuYuan GaoBin LiJiaxin JiangHuirong GuoXianzhi LiuHongxing HuangYuqi ChengHualin YuJie HuXi WuWei WangZhen Wang
Published in: Brain sciences (2022)
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.
Keyphrases
  • deep brain stimulation
  • double blind
  • obsessive compulsive disorder
  • placebo controlled
  • parkinson disease
  • clinical trial
  • phase iii
  • phase ii
  • study protocol
  • randomized controlled trial
  • type diabetes
  • cross sectional