Background: Repetitive transcranial magnetic stimulation (rTMS) is a technique for stimulating brain activity using a transient magnetic field to induce an electrical current in the brain producing depolarization of focal groups of brain cells. TMS is a protocol approved by the U.S. Food and Drug Administration in routine clinical practice as a treatment for depression. A major limitation of rTMS is the large amount of time taken for a standard protocol (38 min a day for 20-30 working days). The optimal type and duration of TMS are still uncertain, as is the optimal strategy for continuing or changing the type of rTMS if there is a poor initial response.
Objectives: The trial aims to assess whether a 1-week compressed course of left dorsolateral prefrontal (L DLPFC) 5 Hz accelerated rTMS (aTMS) treatment is as effective as an established 4-week course of non-accelerated rTMS and if additional 5 Hz L DLPFC aTMS treatments will be efficacious in non-responders as compared to 1 Hz right DLPFC aTMS treatment.
Methods: A randomized, single-blind, delayed-start trial was planned to commence in Jan 2020. A total of 60 patients will be enrolled from the Institute of Mental Health Singapore within a 2-year period and randomized into the early or delayed-start phase of the trial. The primary outcome of the trial is the improvement of Montgomery-Asberg Depression Rating scale at the end of the active treatment phase.
Discussion: If this study protocol proves to be effective, the findings of this trial will be updated to the College of Psychiatrists, Academy of Medicine Singapore, as well as published in a peer-reviewed journal to enhance local and international TMS treatment guidelines.
Trial registration: ClinicalTrials.gov ID: NCT03941106.