Efficacy and Safety of Repetitive Transcranial Magnetic Stimulation Using an H1-Coil or Figure-8-Coil in the Treatment of Unipolar Major Depressive Disorder: A Study Protocol for a Randomized Controlled Trial

Abstract

Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive technique with few side effects that has been reported to be effective in the treatment of major depressive disorder (MDD). At present, no randomized controlled trials (RCT) have compared the efficacy and safety of rTMS delivered by the figure-8-coil and the H1-coil. We describe an industry-independent, randomized, controlled, single-blinded, single-center study protocol assessing the differences in efficacy and safety of rTMS for patients diagnosed with MDD with the H1-coil and figure-8-coil as an add-on to stable pharmacotherapy or pharmacotherapy alone. Stimulation protocols follow those that led to the FDA clearance of these treatments for MDD. The sample of 76 patents in each of the three groups will be enrolled and assessed with clinical and neuropsychological tests. The primary outcome is remission rate defined as Hamilton depression rating scale (HAM-D17) score ≤7 at the end of week-4. This clinical trial will address the efficacy and safety of rTMS modalities for MDD. The evaluation of biological markers will also help to elucidate the pathophysiology of MDD and the mechanisms of action of rTMS.

The Effect of sequential bilateral low‐frequency rTMS over dorsolateral prefrontal cortex on serum level of BDNF and GABA in patients with primary insomnia

“…In recent years, researchers have found that rTMS has an advantage of improving sleep quality, optimizing sleep structure, and maintaining therapeutic efficacy over pharmacological treatments and cognitive behavioral interventions (Aleman, ). rTMS is particularly safe for the treatment of pregnant and lactating women, the elderly, and other special populations with insomnia (Felipe & Ferrão, ; Filipčić et al, ). However, the optimal rTMS parameters have not yet been determined.…”

Past, present, and future of deep transcranial magnetic stimulation: A review in psychiatric and neurological disorders

“…Moreover, the therapeutic impact of DTMS persisted throughout the 16-wk maintenance phase, proving to be advantageous for patients who had previously shown no response to alternative treatments[ 15 ]. The study findings revealed a remission rate of 60% [95% confidence interval (95%CI): 48%-71%] in the DTMS group, whereas the remission rate for rTMS with conventional figure-of-eight coils was 43% (95%CI: 31%-55%)(Table 1 )[ 16 - 22 ]. In a meta-analysis conducted in 2019, it was observed that the DTMS group exhibited a response rate of 47.8%, whereas the sham group demonstrated a response rate of 25.6%.…”