This 3-arm randomized controlled trial tested two forms of personalized accelerated intermittent theta burst stimulation (aiTBS) — fMRI-connectivity-individualized and EEG+fMRI frequency/connectivity-individualized — versus sham in 51 adults with treatment-resistant depression (TRD), delivering 10 sessions/day for 5 days with follow-up at 1 and 4 weeks post-treatment.
Neither active aiTBS arm (fMRI-individualized or EEG+fMRI-individualized) showed significant improvement in depression severity (MADRS) or anhedonia (DARS) compared to sham at 1 week post-treatment; remission and response rates also did not differ between arms.
Small sample size (43 per-protocol completers across 3 arms) limits statistical power; the trial was conducted at a single center, and overall therapeutic effects were described as 'muted,' raising questions about whether the sham condition itself was partly therapeutic or whether TRD patients in this sample had particularly refractory illness.
Clinicians should not yet adopt rs-fMRI- or EEG-personalized aiTBS as a superior alternative to standard TBS protocols for TRD; further larger trials are needed to determine whether individualization of target site and stimulation frequency confers meaningful clinical benefit.
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