Pilot randomized controlled trial of transcranial magnetic stimulation for the treatment of insomnia in cancer survivors: An efficacy, safety, and feasibility therapy

Abstract Nearly 60% of cancer survivors experience insomnia symptoms, which is 2–3 times higher than the general population. This study examined the efficacy, safety, and feasibility of repetitive transcranial magnetic stimulation (rTMS) for the treatment of insomnia in cancer survivors. Sixty‐six cancer survivors with insomnia were randomly assigned to receive rTMS ( n = 22), Sham‐rTMS ( n = 21), and CBT‐I ( n = 23) treatment for a 6‐week period. Participants completed assessments at baseline, 3 weeks, and 6 weeks, respectively. The primary outcome was the change in Insomnia Severity Index (ISI) and Pittsburgh Sleep Quality Index (PSQI) from baseline to 6 weeks. The secondary outcome included the change in Hospital Anxiety and Depression Scale (HADS) and Epworth Sleeping Scale (ESS). The generalized estimating equations (GEE) analysis showed a significant difference in reduced ISI ( β = −4.58, 95% CI −8.25, −0.91, p = .009) and PSQI ( β = −2.35, 95% CI −4.63, −0.07, p = .041) between intervention rTMS and Sham‐rTMS, respectively. A significant between‐group difference was also observed in reduced ESS ( β = −4.65, 95% CI −8.24, −1.06, p = .006). However, the GEE analysis showed that there was no difference between rTMS and CBT‐I for relieving insomnia symptoms and daytime sleepiness. After the 6‐week treatment, rTMS, Sham‐rTMS, and CBT‐I demonstrated 60.0%, 28.6%, and 61.5% response rates for insomnia severity and 66.7%, 35.7%, and 53.8% for sleep quality improvement. The rate of adverse events was 9.1%, 0%, and 4.3% in the rTMS, Sham‐rTMS, and CBT‐I groups, respectively, and no serious adverse events were reported. Given the critical role of good sleep for cancer prognosis, there is an urgent need to increase access to evidence‐based treatment for insomnia in cancer survivors. TMS offers an efficacy, safety, and feasibility therapy.