NCT07487454

Sham-Controlled Rapid-Acting Neuromodulation for Depression

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 264 (estimated)
• Sponsor: University of California, Davis · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Depression - Major Depressive Disorder

Interventions

Type	Name	Description
DEVICE	intermittent theta burst stimulation	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.
DEVICE	Sham (No Treatment)	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.

Timeline

• Start date: 2026-05-01
• Primary completion: 2027-05-01
• Completion: 2028-05-01
• First posted: 2026-03-23
• Last updated: 2026-03-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study