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Prospective Cohort Study of Response and Tolerability of Accelerated Intermittent Theta-burst Stimulation (1W-AiTBS)

Prospective Cohort Study of Response and Tolerability of Accelerated Intermittent Theta-burst Stimulation (1W-AiTBS)

Recruiting
18 years and older
All
Phase N/A

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Overview

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

Study details
    Depression

NCT07449338

Vastra Gotaland Region

27 June 2026

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