Repetitive transcranial magnetic stimulation for insomnia in patients with autism spectrum disorder: Study protocol for a randomized, double-blind, and sham-controlled clinical trial

This study is designed to be a double-blind, randomized, and sham-controlled trial with a target sample size of 30 participants (aged 3–13 years) diagnosed with ASD comorbid with insomnia. The intervention phase will comprise 20 sessions of rTMS or sham rTMS applied over the right dorsolateral prefrontal cortex (DLPFC) within four consecutive weeks. The effect of rTMS on insomnia and other symptoms of ASD will be investigated through home-PSG (two consecutive overnights), sleep diary, CSHQ, CARS, ABC, SRS, RBS-R, and metabolomics analysis at baseline and posttreatment. A follow-up assessment 1 month after the intervention will examine the long-term effects.DiscussionThe results of this study may address an important knowledge gap and may provide evidence for the use of rTMS to treat insomnia in ASD. Furthermore, it will elucidate the potential mechanism and link between sleep disorders and clinical symptoms.Clinical trial registrationThe study is ongoing and has been registered at the Chinese Clinical Trial Registry (ChiCTR2100049266) on 28/07/2021.
Source: Frontiers in Psychiatry - Category: Psychiatry Source Type: research