High-Frequency Neuronavigated Repetitive Transcranial Magnetic Stimulation for Depression in Major Neurocognitive Disorders: A Randomized Controlled Trial

Abstract

Background: We evaluated the safety and efficacy of high-frequency repetitive transcranial magnetic stimulation (HF-rTMS) in major neurocognitive disorder (NCD) patients with depression.Methods: In this single blind, sham-controlled clinical trial, 58 patients of major NCD with clinically significant depressive symptoms (Cornell Depression Scale for Dementia, CSDD ≥ 7) were enrolled and randomly (1:1) assigned for a three-week treatment of either active rTMS (10 Hz, 120% motor threshold, 1500 pulses/session) or sham (placebo-controlled) rTMS treatment. Structural magnetic resonance imaging (MRI) scans were employed to localize the stimulation targets and guide the TMS coil during the treatment. Severity of depressive symptoms, global cognitive function and the serum brain-derived neurotrophic factor (BDNF) level were evaluated at baseline, post-intervention and 6-weeks and 12-weeks follow-ups. Results: Twenty-seven participants were randomized to receive active rTMS and 28 to receive sham rTMS. Both groups showed improvement in depressive symptoms and cognitive function after 3 weeks rTMS treatment. Logistic regression analysis revealed that older age (p = 0.016), higher baseline cognitive function (p = 0.041) and randomization group (p = 0.025) were associated with the remission of depression (Nagelkerke R2 = 0.42). Conclusions: A 3-week course of 10 Hz rTMS appears to be a safe intervention for bringing quicker remission of depression for neurocognitive disorder patients. Trial registration: ClinicalTrials.gov, ChiCTR-IOR-16008191. Registered on March 30, 2016.