The goal of this study is to learn whether 5 days of accelerated intermittent theta burst stimulation (iTBS), a rapid form of transcranial magnetic stimulation (TMS), which is a non-invasive procedure that uses magnetic fields to stimulate brain activity, works to treat depression in adults. The main questions it aims to answer are: * Does accelerated iTBS reduce depressive symptoms compared to sham (placebo) stimulation? * Are there measurable brain, biological, and digitally measured emotion changes associated with treatment response? Participants will: * Be randomly assigned to receive either active iTBS or sham stimulation * Receive 10 stimulation sessions per day for 5 consecutive days (total of 50 sessions) * Complete MRI brain scans and EEG recordings before and after treatment * Provide blood and saliva samples to measure biological markers * Complete depression rating scales and questionnaires at baseline, during treatment, and at follow-up visits * Use a secure mobile app to record brief facial and vocal samples during the 5-day treatment and at follow-up visits * Return for follow-up visits at 1 week and at 1, 3, 6, and 12 months after treatment
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
264
The TMS protocol involves delivering sessions of intermittent theta burst stimulation (iTBS) of 60 cycles of 10 bursts of three pulses at 50 Hz delivered in 2-second trains (5 Hz) with an 8-second intertrain interval. Stimulation sessions will be delivered hourly. Ten sessions will be applied per day (18,000 pulses/day) for 5 consecutive days (90,000 pulses in total). Stimulation will be delivered at 90% resting motor threshold (rMT). For safety, stimulation will never be delivered above 120% rMT. Participants assigned to the sham group will receive treatment using a sham TMS coil.
Participants assigned to the sham group will receive treatment using a sham TMS coil. This coil looks and sounds similar to the active coil but does not deliver magnetic pulses to the brain.
UC Davis Medical Center
Sacramento, California, United States
Montgomery-Åsberg Depression Rating Scale (MADRS)
Change in depressive symptoms (MADRS scores)
Time frame: Baseline through study completion, 1 year
Change in large-scale brain network connectivity measured by fMRI
Change in resting-state functional connectivity within and between large-scale brain networks associated with depression, including the default mode network, salience network, and central executive network.
Time frame: Baseline through study completion, 1 year
Change in electroencephalography (EEG) spectral power
Change in resting-state electroencephalography (EEG) spectral power across frequency bands (delta, theta, alpha, beta, and gamma).
Time frame: Baseline through study completion, 1 year
Change in facial and vocal affective expression
Change in multimodal affective dynamics derived from combined facial and vocal recordings using machine learning-based analysis to generate composite measures of emotional expression and variability.
Time frame: Baseline through study completion, 1 year
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