mPFC-rTMS for patients with insomnia disorder using resting-state functional magnetic resonance imaging: a protocol for a randomized controlled trial.

Background: Insomnia is the most common sleep disorder. Repetitive transcranial magnetic stimulation (rTMS) is safe and effective for insomnia disorder (ID). Convergent evidence show that the medial prefrontal cortex (mPFC) may be involved in the regulation of sleep and awakening at the cortical level and may serve as a potential target of rTMS in the treatment of ID. The purpose of this clinical trial is to study the efficacy of mPFC-rTMS in the treatment ID and explore the neural mechanism using resting-state functional magnetic resonance imaging (fMRI).

Methods And Design: This will be a parallel-group randomized, patient- and assessor-blinded trial. The study will recruit 60 ID patients assigned to a real mPFC-rTMS group or a sham mPFC-rTMS group. The allocation ratio is 1:1, with 30 subjects in each group. Interventions will be administered five times per week over a 4-week period, with an 8-week follow-up period. All participants will undergo neuropsychological and fMRI evaluations. The primary outcome measure of this study is the change scores of the Pittsburgh Sleep Quality Index (PSQI). The secondary outcome measures include the fMRI measurements, the Hamilton Depression Scale (HAMD), the Hamilton Anxiety Scale (HAMA), a sleep diary, and a polysomnography. Assessment of all parameters will be performed at baseline, post-treatment, and during follow-up.

Discussion: It is expected that the study results will provide strong evidence of the effectiveness and the neural mechanism by which mPFC-rTMS improves sleep quality in ID patients.

Trial Registration: Chinese Clinical Trials Register ChiCTR2100054154. Registered on 10 December 2021.