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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active iTBS | Experimental | The active iTBS group will receive 10 hourly intermittent theta burst stimulation (iTBS) sessions per day for 5 consecutive days. |
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| Sham iTBS | Sham Comparator | Participants assigned to the sham group will receive 10 hourly sham sessions per day for 5 consecutive days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intermittent theta burst stimulation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Montgomery-Ã…sberg Depression Rating Scale (MADRS) | Change in depressive symptoms (MADRS scores) | Baseline through study completion, 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline through study completion, 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Manpreet K Singh, MD, MS | Contact | 916-734-2011 | mpksingh@health.ucdavis.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Davis Medical Center | Sacramento | California | 95817 | United States |
De-identified individual participant data (IPD) of the results reported in publications may be made available upon reasonable request. Requests will be reviewed by the Principal Investigator to ensure that the proposed use is scientifically appropriate and consistent with participant consent and institutional policies.
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| Sham (No Treatment) | Device | 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. |
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| Change in electroencephalography (EEG) spectral power |
Change in resting-state electroencephalography (EEG) spectral power across frequency bands (delta, theta, alpha, beta, and gamma). |
| 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. | Baseline through study completion, 1 year |