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

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.