A Novel Individualized Connectome-guided Approach for Precision Intermittent Theta Burst Stimulation for Depression: a Double Blind, Randomized Controlled Trial

What this Trial Is About

Researchers are conducting a randomized, double-blind trial to compare two types of accelerated intermittent theta burst stimulation (iTBS) treatments for depression. The study aims to evaluate the clinical effectiveness of an individualized connectome-guided iTBS versus an anatomically-guided (Beam F3) iTBS approach. The trial includes both inpatients and outpatients referred for transcranial magnetic stimulation (TMS) as a treatment for major depressive episodes. Participants will receive one of two study treatments delivered using a MagVenture MagPro X100 system with a butterfly-shaped MagVenture Cool-B65 A/P coil. Both groups undergo an accelerated iTBS treatment course consisting of 10 sessions daily for 5 consecutive workdays, totaling 50 sessions. Each session lasts about 10 minutes and is delivered at a depth-corrected resting motor threshold of 90%, with specific pulse and timing parameters. The treatments are administered by trained staff following professional guidelines. During the study, participants will have their depression symptoms assessed using the Montgomery-Åsberg Depression Rating Scale at baseline, immediately after treatment, and at 1 and 3 months post-intervention. Additional evaluations include self-reported depressive symptoms, cognitive assessments, quality of life measures, and satisfaction questionnaires at similar time points. Safety and adherence are monitored throughout, with the total participation spanning the treatment period and follow-up visits over three months.

A Novel Individualized Connectome-guided Approach for Precision Intermittent Theta Burst Stimulation for Depression