Study Comparing Two Intensities of Intermittent Theta-burst Stimulation for Major Depression Lower Versus Standard Stimulation Intensity and Sham Control A 4-Week Randomized Clinical Trial

What this Trial Is About

Researchers are investigating the use of intermittent theta-burst stimulation iTBS, a form of repetitive transcranial magnetic stimulation approved by the FDA in 2018, to treat major depressive disorder MDD. This study focuses on comparing the antidepressant effects of iTBS at different stimulation intensities 75% and 120% of the resting motor threshold rMT, against a sham control. The goal is to determine whether lower stimulation intensities can provide effective treatment with less discomfort and better adherence compared to the currently standard 120% rMT intensity. Participants will be randomly assigned to one of three groups sham iTBS inactive coil side, iTBS at 75% rMT, or iTBS at 120% rMT. Each group will receive 20 daily sessions over four weeks, Monday through Friday. Treatments will be delivered using a MagPro X100 device with a Cool-B65 AP Butterfly Coil, targeting the left dorsolateral prefrontal cortex DLPFC based on EEG positioning. The study is conducted at the brain stimulation laboratory of the Hong Kong Polytechnic University. During the study, participants will undergo assessments including the Montgomery-Asberg Depression Rating Scale MADRS, Patient Health Questionnaire-9 PHQ-9, Subjective Happiness Scale SHS, and pain level ratings, all measured over the one-month treatment period. Researchers will monitor depressive symptoms, mood, happiness, and treatment tolerability. The study aims to evaluate the clinical benefits and side effects related to different stimulation intensities and improve treatment adherence for patients with MDD.

Intermittent Theta-burst Stimulation for Major Depression: an Intensity-response Study