One-Day cTBS Over the Precuneus and iTBS Over the Left PFC for Treatment-Resistant Depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this randomized, three-arm trial, adults with treatment-resistant depression receive either precuneus-targeted continuous theta-burst stimulation (cTBS), left frontal stimulation with intermittent theta-burst stimulation (iTBS), or sham TMS in an accelerated, one-day protocol. The precuneus is stimulated with a double-cone coil to reach the medial posteromedial cortex, while the left dorsolateral prefrontal cortex is targeted with iTBS, to compare network-based and established approaches. Participants are assigned using minimal sufficient balance randomization, considering sex and baseline depression severity. Depression outcomes are assessed four weeks after treatment using validated scales, with safety monitoring throughout.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18 years or older.
* Able to speak, read, and understand English sufficiently to complete the study assessments and provide informed consent independently.
* Diagnosis of major depressive disorder according to DSM-5-TR criteria, confirmed by a qualified physician.
* Treatment-resistant depression, defined as an inadequate response to at least two adequate trials of antidepressant pharmacotherapy.
* Patient Health Questionnaire-9 (PHQ-9) total score of 10 or higher.

Exclusion Criteria:

* Any condition identified through TMS safety screening that, in the judgment of a study physician, presents an unacceptable safety risk for TMS. Such conditions may include:
* A history of a serious adverse reaction during TMS treatment.
* A history of seizure.
* A history of stroke.
* A history of serious head injury or neurosurgery.
* Metal in the head outside the mouth, such as shrapnel, surgical clips, or metal fragments.
* An implanted device, such as a cardiac pacemaker, cochlear implant, medical pump, or intracardiac line.
* Frequent or severe headaches.
* Another brain-related condition or an illness that caused brain injury.
* A family history of epilepsy.
* Permanent tattoos on the head or neck.
* Current recreational drug use.
* Current pregnancy or possible pregnancy.
* Use of a medication or combination of medications, a recent medication change, or medication withdrawal that, in the judgment of a study physician, presents an unacceptable safety risk, including a clinically significant increase in seizure risk.
* Current or lifetime diagnosis of bipolar I disorder, bipolar II disorder, a schizophrenia spectrum disorder, or another primary psychotic disorder.
* Active suicidal ideation with intent or plan requiring immediate clinical intervention, or another acute safety concern that cannot be safely managed within the study.

Where it's running

• McLean Hospital
  Belmont, Massachusetts, United States Recruiting

Study contacts

• Study coordinator: Hakjoo Kim Kim, Ph.D.
• Email: khj213@gmail.com
• Phone: 979-777-0679

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.