Prospective Cohort Study of Response and Tolerability of Accelerated Intermittent Theta-burst Stimulation (1W-AiTBS)
NCT07449338
Summary
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.
Eligibility
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * any condition that seriously increases the risk of non-compliance or loss of follow-up
Conditions1
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NCT07449338