Treating insomnia in mild cognitive impairment: a novel approach combining transcranial magnetic stimulation with cognitive behavioral therapy

Insomnia is a common comorbidity of mild cognitive impairment (MCI). Poor sleep is linked to worsening quality of life and faster cognitive decline. Cognitive behavioral therapy for insomnia (CBT-I) is the recommended first-line non-pharmacologic treatment in older adults, but the neurocognitive complications of MCI can hinder the ability to engage with and adhere to CBT-I. Since daily applications of repetitive transcranial magnetic stimulation (rTMS) have been shown to improve memory and global cognition in persons with MCI, we hypothesize that combining rTMS with CBT-I will yield a synergistic effect, resulting in better sleep quality and cognition than CBT-I alone. This ongoing Phase I/II trial (NCT06687161), conducted as a dual-arm (dose-response) open-label study, is testing the feasibility and preliminary efficacy of this combined approach in 30 persons with insomnia symptoms and either MCI or subjective cognitive impairment. Outcomes from this cohort will be compared to a matched cohort receiving CBT-I alone in a separate clinical trial (NCT05565833). Combining rTMS and CBT-I aims to meet the need for an efficacious non-pharmacologic therapy for persons with MCI and insomnia. If successful, this approach can be made widely accessible by coupling internet-delivered CBT-I with the rapidly growing number of sites offering outpatient rTMS therapy. TRIAL REGISTRATION: Clinicaltrials.gov NCT06687161 (registered November 12, 2024). https://clinicaltrials.gov/study/NCT06687161.