Effectiveness of accelerated intermittent theta burst stimulation for social cognition and negative symptoms among individuals with schizophrenia: A randomized controlled trial

Background: Social cognitive and negative symptoms impairment may increase the risk of mental disability in individuals with schizophrenia. However, randomized controlled studies on the effectiveness of accelerated intermittent theta burst stimulation (iTBS) for social cognition and negative symptoms in individuals with schizophrenia are very limited. Methods: A total of 125 individuals with schizophrenia were recruited, 66 of whom were randomly divided into an active iTBS group (n=34) and sham iTBS group (n=32) by stratified sampling. Participants received either active iTBS or sham iTBS targeting the left dorsolateral prefrontal cortex (DLPFC) 20 sessions for 4 weeks under navigation. The Facial Emotion Recognition Test (FERT), Hinting Task (HT), and Positive and Negative Syn-drome Scale (PANSS) were measured at baseline, 2 weeks, and 4 weeks. The trial protocol was registered with the Chinese Clinical Trial Registry (ChiCTR2100051984). Results: Sixty patients (90.90%) completed the intervention and the 4-week follow-up, including 29 women (43.94%) and 37 men (56.06%) with a mean (SD) age of 47.53 (10.17) years. The primary outcomes showed FERT scores (week 2; 0.27 [95% CI, 0.09 to 0.45]; P< .01; ES 0.14) (week 4; 0.63 [95% CI, 0.45 to 0.80]; P< .001; ES 0.47) and HT scores (week 2; 1.00 [95% CI,-0.02 to 1.98]; P< .05; ES 0.67) (week 4; 2.13 [95% CI, 1.21 to 3.06]; P< .001; ES 0.27) in the active iTBS group were significantly different from those in the sham iTBS group at 2 and 4 weeks of follow-up. The secondary outcome showed that the negative symptom score (-3.43 [95% CI,-4.85 to-2.01]; P< .001; ES 0.29) of the active iTBS group was significantly different from that of the sham iTBS group at the 4th week of follow-up. Conclusions: Accelerated iTBS can effectively ameliorate the social cognition and negative symptoms of in-dividuals with schizophrenia. These results suggest that accelerated iTBS may be a safe and effective neuro-modulation technique to improve the overall functional recovery of individuals with schizophrenia, and has a good clinical application prospect.