Study Comparing Two Types of Theta Burst Stimulation Treatments for Adults With Major Depression and Follow-Up Maintenance

What this Trial Is About

Researchers are evaluating the effects of theta burst stimulation TBS, a newer form of repetitive transcranial magnetic stimulation rTMS, in treating people with major depressive episodes. This study compares the effectiveness of stimulating one side unilateral versus both sides bilateral of the brains frontal cortex. It also explores brain activity changes and neural markers that may predict treatment response. Additionally, the study examines a flexible maintenance treatment schedule to help prevent relapse over six months in those who respond to initial therapy. Participants will receive TBS treatments daily on weekdays for 4 to 6 weeks, stopping at 4 weeks if remission is achieved. Two groups receive either unilateral or bilateral TBS unilateral involves intermittent TBS on the left side with sham treatment on the right, while bilateral delivers active TBS to both sides. Responders enter a 6-month maintenance phase with a flexible schedule based on symptom assessments using the Hamilton Rating Scale for Depression-17. Maintenance frequency starts at twice weekly, then adjusts monthly through clinical evaluations. Throughout the study, participants undergo regular assessments including depression rating scales and brain activity measurements using TMS-EEG. Researchers track response and remission rates at key points end of treatment and after 6 months of maintenance. Safety and treatment adherence are monitored closely. The total participation time can last up to about 7.5 months including treatment and maintenance. This study aims to better understand how TBS can be optimized for depression and how to maintain its benefits over time.

Comparing Uni- and Bi-lateral TBS in Major Depression