Model-driven individualized transcranial direct current stimulation for the treatment of insomnia disorder: protocol for a randomized, sham-controlled, double-blind study

Insomnia disorder is a prevalent condition associated with significant negative impacts on health and daily functioning. Transcranial direct current stimulation (tDCS) has emerged as a potential technique for improving sleep. However, questions remain regarding its clinical efficacy, and there is a lack of standardized individualized stimulation protocols. This study aims to evaluate the efficacy of model-driven, individualized tDCS for treating insomnia disorder through a randomized, double-blind, sham-controlled trial. A total of 40 patients diagnosed with insomnia disorder will be recruited and randomly assigned to either an active tDCS group or a sham stimulation group. Individualized stimulation parameters will be determined through machine learning-based electric field modeling incorporating structural MRI and EEG data. Participants will undergo 10 sessions of tDCS (5 days/week for 2 consecutive weeks), with follow-up assessments conducted at 2 and 4 weeks after treatment. The primary outcome is the reduction in the Insomnia Severity Index (ISI) score at two weeks post-treatment. Secondary outcomes include changes in sleep parameters, anxiety, and depression scores. This study is expected to provide evidence for the effectiveness of individualized tDCS in improving sleep quality and reducing insomnia symptoms. This integrative approach, combining advanced neuroimaging and electrophysiological biomarkers, has the potential to establish an evidence-based framework for individualized brain stimulation, optimizing therapeutic outcomes. This study is registered at ClinicalTrials.gov (Identifier: NCT06671457) and was registered on 4 November 2024.