EEG-Guided TMS for Depression

(CLEOPATRA Trial)

This trial aims to determine if brain wave recordings (EEG) can enhance a depression treatment called intermittent theta burst stimulation (iTBS), a type of magnetic therapy. Participants will receive this treatment with pulses timed to specific brain wave phases to identify the most effective timing. The study targets individuals diagnosed with Major Depressive Disorder (MDD) who have not found relief from at least one antidepressant medication. As an unphased trial, it offers participants the chance to contribute to innovative research that could improve future depression treatments.

The trial requires that you have no changes in your psychotropic medications for 4 weeks before screening, and you cannot be taking bupropion/Wellbutrin or antipsychotics. Other medications are not specifically mentioned, so it's best to discuss with the trial staff.

Research has shown that intermittent theta burst stimulation (iTBS) is generally safe and well-tolerated for treating depression. Studies have found that iTBS can cause mild and temporary side effects like tiredness, dizziness, and brief eye movements called nystagmus. These side effects are not serious and usually resolve quickly.

One study compared iTBS to a longer standard treatment for depression. The results indicated that iTBS had similar side effects to the standard treatment, suggesting comparable safety.

Researchers are excited about EEG-guided TMS for depression because it offers a new way to personalize brain stimulation. Unlike traditional treatments like antidepressant medications or ECT, this approach uses EEG data to tailor the timing of stimulation to each patient's unique brain activity. Specifically, the treatment aligns the stimulation bursts with either the peak or trough of individual theta brain waves, potentially enhancing its effectiveness. This personalized method could lead to more rapid and significant improvements in depression symptoms, offering hope for patients who haven't responded to standard therapies.

Research has shown that intermittent theta burst stimulation (iTBS), a type of transcranial magnetic stimulation (TMS), can effectively reduce symptoms of major depressive disorder (MDD). Studies have found that iTBS significantly improves mood and overall mental health. The FDA has approved this treatment, confirming its safety and effectiveness. In this trial, participants will receive EEG-guided iTBS, with different arms testing various timing strategies. One arm will synchronize stimulation bursts to the peak of individual theta oscillations, another to the trough, and a third will apply stimulation at a random phase. By matching the stimulation with specific brainwave patterns, researchers aim to improve treatment results for depression.