Personalized Accelerated Brain Circuit Therapy Using Intermittent Theta-Burst Stimulation for Treatment Resistant Depression

What this Trial Is About

Researchers are evaluating a new accelerated and personalized transcranial Magnetic Stimulation TMS treatment called CoMPACT for adults with Treatment Resistant Depression TRD. This randomized, double-blinded, sham-controlled trial aims to test whether targeting specific brain areas with intermittent theta-burst stimulation iTBS can reduce depression symptoms. The study uses personalized electrical field modeling based on brain scans to tailor the treatment and explores brain activity changes through EEG and MRI imaging to better understand how the treatment works. Participants will receive 25 iTBS sessions over five consecutive days, with five sessions each day targeting either the left dorsolateral prefrontal cortex DLPFC, the left inferior parietal lobule IPL, or a sham version targeting these areas. Each session lasts about 10 minutes with rest periods between sessions. The sham treatment mimics the real stimulation experience without active pulses to ensure blinding. The study includes detailed brain monitoring during and after treatment to assess changes in brain networks related to depression. During the trial, participants undergo assessments of depression severity, cognitive function, well-being, anxiety, mood, sleep quality, and side effects before, immediately after, and up to four weeks following treatment. EEG recordings are taken during treatment days to observe brain activity changes. Structural and functional MRI scans are performed before and after treatment to study brain network alterations. Non-responders may be offered standard TMS therapy after the trial. Participants are involved for several weeks, including follow-up visits to track long-term effects and safety.

COpenhagen Magnetic Personalized Accelerated Brain Circuit Therapy for Treatment Resistant Depression