Sham-Controlled Rapid-Acting Neuromodulation for Depression

Part of paid clinical trials in Sacramento, California.

Sponsor
University of California, Davis
Study ID
NCT07487454
Status
Not Yet Recruiting

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Conditions

  • Depression - Major Depressive Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • 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.

Study Details

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

Key Dates

Start date
May 31, 2026
Status verified
Mar 2026
Primary completion
May 31, 2027
Completion
May 31, 2028

Study Design

Enrollment
264 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Active iTBS
    The active iTBS group will receive 10 hourly intermittent theta burst stimulation (iTBS) sessions per day for 5 consecutive days.
  • Sham Comparator: Sham iTBS
    Participants assigned to the sham group will receive 10 hourly sham sessions per day for 5 consecutive days.

Primary Outcome Measure

Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: Baseline through study completion, 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UC Davis Medical CenterSacramentoCalifornia95817
Manpreet K Singh, MD, MS
[email protected]
916-734-2011

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By research site
UC Davis Medical Center· Sacramento, CA

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