Intermittent Theta Burst Stimulation for Depression
What You Need to Know Before You Apply
What is the purpose of this trial?
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
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 10 stimulation sessions per day for 5 consecutive days, totaling 50 sessions of either active iTBS or sham stimulation. MRI brain scans, EEG recordings, and biological samples are collected.
Follow-up
Participants are monitored for safety and effectiveness after treatment with follow-up visits at 1 week, and at 1, 3, 6, and 12 months. Depression rating scales and questionnaires are completed, and facial and vocal samples are recorded.
What Are the Treatments Tested in This Trial?
Interventions
- Intermittent Theta Burst Stimulation
- Sham (No Treatment)
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
The active iTBS group will receive 10 hourly intermittent theta burst stimulation (iTBS) sessions per day for 5 consecutive days.
Participants assigned to the sham group will receive 10 hourly sham sessions per day for 5 consecutive days.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, Davis
Lead Sponsor
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