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Sham-Controlled Rapid-Acting Neuromodulation for Depression

NCT07487454 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 264

Last updated 2026-03-23

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • University of California, Davis

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2027-05-31
Completion
2028-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07487454 on ClinicalTrials.gov