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NCT Number: NCT07487454

Sham-Controlled Rapid-Acting Neuromodulation for Depression

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

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Key information

Conditions

Depression - Major Depressive Disorder

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UC Davis Medical Center

Sacramento, California, 95817, United States

Location contact

Manpreet K Singh, MD, MS

CONTACT

[email protected]

916-734-2011

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • English speaking
  • Able to provide informed consent
  • 18-65 years old
  • Meets MDD criteria per the Mini International Neuropsychiatric Interview (MINI)

Exclusion criteria

  • Unable to consent (due to medical condition, acute psychosis, substance use, etc)
  • Use of benzodiazepines or medications that would interfere with TMS treatment as per PI discretion
  • Active substance use or severe substance use that in the opinion of the PI would interfere with study participation
  • Untreated, active psychosis
  • Female patient who is breastfeeding, pregnant or who is planning a pregnancy during the study
  • Contraindications to receiving TMS and/or MRI as determined by screening questionnaires
  • Participation in any clinical study with exposure to any investigational treatment or product within the previous 30 days, or plan on concurrent participation in other studies.

Treatment and study plan

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.

Primary outcomes

  1. Montgomery-Åsberg Depression Rating Scale (MADRS)

    Time frame: Baseline through study completion, 1 year

    Change in depressive symptoms (MADRS scores)

Secondary outcomes

  1. Change in large-scale brain network connectivity measured by fMRI

    Time frame: Baseline through study completion, 1 year

    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.

  2. Change in electroencephalography (EEG) spectral power

    Time frame: Baseline through study completion, 1 year

    Change in resting-state electroencephalography (EEG) spectral power across frequency bands (delta, theta, alpha, beta, and gamma).

  3. Change in facial and vocal affective expression

    Time frame: Baseline through study completion, 1 year

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Manpreet K Singh, MD, MS

CONTACT

[email protected]

916-734-2011

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Mar 23, 2026
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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