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One-Day cTBS Over the Precuneus

Sponsor: Mclean Hospital • ClinicalTrials.gov ID: NCT07758010

Registry updated: 2026-09-11

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Description

The goal of this clinical trial is to learn whether two forms of one-day accelerated transcranial magnetic stimulation (TMS) can reduce depressive symptoms in adults with treatment-resistant depression. Treatment-resistant depression is depression that has not improved enough after at least two adequate antidepressant medication treatments. TMS is a non-invasive treatment that uses magnetic pulses to stimulate specific areas of the brain. The main questions this study aims to answer are: * Does continuous theta-burst stimulation (cTBS) targeting the precuneus reduce depressive symptoms 4 weeks after treatment compared with sham stimulation? * Does intermittent theta-burst stimulation (iTBS) targeting the left dorsolateral prefrontal cortex reduce depressive symptoms 4 weeks after treatment compared with sham stimulation? Researchers will compare precuneus cTBS, left dorsolateral prefrontal cortex iTBS, and sham stimulation to determine whether either active treatment reduces depressive symptoms more than sham stimulation. Participants will be randomly assigned to one of the three groups and will not be told which treatment they initially receive. Participants will: * Complete screening procedures and baseline assessments of depression, rumination, and cognitive function * Receive 20 sessions of active or sham TMS during one in-person study day * Complete follow-up assessments 1, 2, 3, and 4 weeks after the intervention * Report any side effects or medical problems experienced during the study Participants initially assigned to sham stimulation may choose to receive active TMS after completing the 4-week follow-up period. Those who choose this option will receive either precuneus cTBS or left dorsolateral prefrontal cortex iTBS and will complete additional follow-up assessments.

Interventions

Precuneus-targeted continuous theta-burst stimulation (Device)
Active continuous theta-burst stimulation is delivered to the Pz location of the international 10-20 EEG system to target the precuneus. Stimulation is administered with a double-cone coil at 80% of the participant's resting motor threshold. Each session consists of 600 pulses delivered over approximately 40 seconds. Participants receive 20 sessions during a single day, for a total of 12,000 pulses, with session onsets separated by approximately 30 minutes. If 80% of resting motor threshold is not tolerated, the intensity may be reduced to the highest tolerable level.
Left dorsolateral prefrontal cortex intermittent theta-burst stimulation (Device)
Active intermittent theta-burst stimulation is delivered to the left dorsolateral prefrontal cortex. The stimulation target is identified using the Beam F3 method. Stimulation is administered with a figure-of-eight coil at 80% of the participant's resting motor threshold. Each session consists of 600 pulses delivered over approximately 3 minutes. Participants receive 20 sessions during a single day, for a total of 12,000 pulses, with session onsets separated by approximately 30 minutes. If 80% of resting motor threshold is not tolerated, the intensity may be reduced to the highest tolerable level.
Sham transcranial magnetic stimulation (Device)
Sham transcranial magnetic stimulation is administered at the left dorsolateral prefrontal cortex location identified using the Beam F3 method. A figure-of-eight coil is inverted so that the active surface faces away from the scalp. The stimulator is operated at 80% of the participant's resting motor threshold using the same intermittent theta-burst timing and approximate session duration as the active left dorsolateral prefrontal cortex intervention. Participants receive 20 sham sessions during a single day, with session onsets separated by approximately 30 minutes.

Eligibility criteria

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.

Conditions

Depressive Disorder, Treatment-Resistant Treatment Resistant Depression (TRD) Treatment Resistant Major Depression Disorder

Locations

McLean Hospital — Belmont, Massachusetts, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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