Intermittent theta-burst stimulation (iTBS), a variant of repetitive transcranial magnetic stimulation (rTMS), is a well-documented treatment for depression. The aim of this study is to evaluate the effectiveness of an accelerated iTBS protocol (1W-AiTBS) in routine clinical practice. In the accelerated protocol, patients receive 600 pulses per session, for a total of 30 sessions administered over 5-14 treatment days. Patient inclusion will take place over a maximum period of 1.5 years, with a maximum sample size of 150 patients. The target sample size is at least 36 patients. Patients will complete self-rating questionnaires at screening, before and after treatment, and at 6 weeks, 12 weeks, and 6 months from the first day of treatment.
diagnosis of depression verified through a Mini International Neuropsychiatric Interview (M.I.N.I.)
provision of signed informed consent form
indication for TMS is depression
conductive ferromagnetic or other metals implanted in the head or within 30 cm of the treatment coil
implanted device that is activated or controlled in any way by physiological signals
implanted mediation pumps
intracardiac lines, even when removed
Patients referred for AiTBS treatment at participating study sites will be invited to participate in the study.
Cohort
Prospective
iTBS (intermittent theta-burst stimulation)
DeviceThe iTBS treatment is a type of rTMS (repetitive transcranial magnetic stimulation), delivered with MagPro R30 stimulator and a conventional cool-B65 coil. The iTBS treatment is applied to over the dorsolateral prefrontal cortex using a standardized measuring of the anatomical landmark F3 from the 10-20 positioning system. The coil is positioned with the handle at in a 45 degree angle from the midline. The centre of the butterfly is placed towards the patient head.
Difference in MADRS-S from baseline to six weeks after first iTBS treatment
The self-rating version of the Montgomery-Asberg Depression Rating Scale (MADRS-S) is a rating scale (0-54 points), where a higher score indicates worse depressive symptoms
Difference in MADRS-S from baseline to after last iTBS treatment
The self-rating version of the Montgomery-Asberg Depression Rating Scale (MADRS-S) is a rating scale (0-54 points), where a higher score indicates worse depressive symptoms
Difference in MADRS-S from baseline to twelve weeks after first iTBS treatment
The self-rating version of the Montgomery-Asberg Depression Rating Scale (MADRS-S) is a rating scale (0-54 points), where a higher score indicates worse depressive symptoms
Difference in MADRS-S from baseline to six months after first iTBS treatment
The self-rating version of the Montgomery-Asberg Depression Rating Scale (MADRS-S) is a rating scale (0-54 points), where a higher score indicates worse depressive symptoms
Difference in SDS from baseline to twelve weeks after first iTBS treatment
The Sheehan Disability Scale (SDS) is a self-rating assessment (0-30 points), where a higher score indicates more pronounced functional impairment
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