An interventional study of Continuous theta-burst stimulation in Depression, sponsored by University Health Network, Toronto. Completed at 1 site in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-05-03.
Sponsored by University Health Network, Toronto · Not applicable, Interventional, and Treatment
This trial will compare the efficacy of active inhibitory OFC-rTMS to sham OFC-rTMS in major depression. The trial will include structural and functional MRI, EEG, and behavioral measures obtained before, during, and after treatment.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 32 is below the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →University Health Network, Toronto is the lead sponsor of 1,411 studies on the registry; 292 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Sham repetitive transcranial magnetic stimulation (rTMS) to right orbitofrontal cortex, twice daily, 5 days per week for 3 weeks, then active rTMS to right orbitofrontal cortex, twice daily, 5 days per week for 3 weeks
Device: Continuous theta-burst stimulation
Active repetitive transcranial magnetic stimulation (rTMS) to right orbitofrontal cortex, twice daily, 5 days per week for 3 weeks, then sham rTMS to right orbitofrontal cortex, twice daily, 5 days per week for 3 weeks
Device: Continuous theta-burst stimulation
17-Item Hamilton Rating Scale for Depression (HAMD-17)
Outcome measured by a change in HAMD-17 score from baseline to 2 weeks post-treatment. A 50% improvement in the score is considered a response to rTMS. A final score of \<8 is categorized as remission.
Time frame: Baseline, after each week of treatment (i.e. after 5 days of treatment) and at 1, 4, and 12 weeks post-treatment.
Beck Depression Inventory-II (BDI-II)
Time frame: Daily for 6 weeks
Magnetic Resonance Imaging (MRI)
10 min resting-state functional MRI (rs-fMRI) at 3 Tesla (3T)
Time frame: 1 week pre- and 1 week post-treatment
Electroencephalography (EEG)
10 min resting-state and task-based (response inhibition, reward sensitivity) acquisitions
Time frame: Day 1 (First day of treatment), Day 15, and Day 30 (Final day of treatment)]
Plan to share: No
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This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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University Health Network, Toronto