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

ConditionDepression
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorVastra Gotaland Region

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • iTBS (intermittent theta-burst stimulation)

Treatment groups

36 Participants
are divided into 1 treatment group

Sponsors and collaborators