Effects of mPFC-rTMS in chronic Insomnia: A randomized, double-blind, placebo-controlled study

Medial prefrontal cortex (mPFC) may play an important role in the pathophysiological mechanism of insomnia and may be a potential target for treating insomnia. Herein, we aimed to investigate the efficacy and safety of repetitive transcranial magnetic stimulation (rTMS) for chronic insomnia.

We conducted a pilot, double-blind, randomized, sham-controlled trial. 62 participants with chronic insomnia were recruited and randomly allocated to either the active or sham rTMS group. Forty-one patients completed 20 sessions of active or sham intervention targeting the mPFC and assessments at baseline, end of intervention, and follow-up.

After 4-week intervention, the response rate and remission rate were significantly higher in the active group (51.7 % and 44.8 %) than those in the sham group (20.8 % and 16.7 %), with p = 0.037 and p = 0.048, respectively. At 4-week follow-up, the response rate and remission rate were not different between groups. There were significant interaction between group and time for insomnia severity using Pittsburgh Sleep Quality Index (PSQI) and sleep onset latency, daily disturbances, and hypnotic drug use. Post hoc analysis revealed that, compared with the sham group, the active group showed significant improvements in insomnia symptoms (except for total sleep time and sleep efficiency) at the end of the 4-week intervention, and significant improvements in PSQI scores, sleep onset latency, sleep efficiency, daily disturbances and hypnotic drug use at the 4-week follow-up. There were no statistically significant difference in adverse events between the two groups, and there were no serious adverse events occurred during treatment.

mPFC-rTMS maybe an effective and safety therapeutic in chronic insomnia.