Transcranial Magnetic Stimulation for Depression
(OcTOPUS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
This trial is for adults with major depressive disorder whose depression has not improved after trying at least two different antidepressant medications. Participants must be able to attend an in-person study day and follow-up visits.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 20 sessions of active or sham TMS during one in-person study day
Follow-up
Participants complete follow-up assessments 1, 2, 3, and 4 weeks after the intervention
Open-label extension (optional)
Participants initially assigned to sham stimulation may opt into continuation of active TMS treatment
What Are the Treatments Tested in This Trial?
Interventions
- Left dorsolateral prefrontal cortex intermittent theta-burst stimulation
- Precuneus-targeted continuous theta-burst stimulation
Trial Overview
The study tests whether one-day sessions of two types of transcranial magnetic stimulation (TMS)—targeting either the precuneus or left prefrontal cortex—can reduce symptoms of treatment-resistant depression, compared to a sham (inactive) TMS. Participants are randomly assigned to one group.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Placebo Group
Participants receive 20 sessions of active continuous theta-burst stimulation (cTBS) targeting the Pz location of the international 10-20 EEG system during a single day. Stimulation is delivered using a double-cone coil at 80% of the participant's resting motor threshold. Each session consists of 600 pulses delivered over approximately 40 seconds, for a total of 12,000 pulses. Session onsets are separated by approximately 30 minutes. If stimulation at 80% of resting motor threshold is not tolerated, the intensity may be reduced to the highest tolerable level.
Participants receive 20 sessions of active intermittent theta-burst stimulation (iTBS) targeting the left dorsolateral prefrontal cortex during a single day. The target is identified using the Beam F3 method, and stimulation is delivered using 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, for a total of 12,000 pulses. Session onsets are separated by approximately 30 minutes. If stimulation at 80% of resting motor threshold is not tolerated, the intensity may be reduced to the highest tolerable level.
Participants receive 20 sessions of sham TMS at the left dorsolateral prefrontal cortex location identified using the Beam F3 method during a single day. A figure-of-eight coil is inverted so that the active surface faces away from the scalp. The device is operated at 80% of the participant's resting motor threshold, and sham stimulation follows the same stimulation pattern and approximate 3-minute duration as active iTBS. Session onsets are separated by approximately 30 minutes. After completing the Week 4 assessment, participants may enter an optional open-label extension and are randomized to receive active precuneus cTBS or left dlPFC iTBS.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mclean Hospital
Lead Sponsor
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