Prospective Cohort Study of Response and Tolerability of Accelerated Intermittent Theta-burst Stimulation (1W-AiTBS)
Recruiting now
Conditions studied: Depression
In brief
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.
Key facts
- Study ID
- NCT07449338
- Run by
- Vastra Gotaland Region
- People needed
- 36
- Starts
- 2026-03-01
- Expected to finish
- 2027-03-01
- Last updated by the study team
- 2026-05-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Sahlgrenska University Hospital — Gothenburg, Sweden (enrolling)
- Kungälv Hospital, Kungälv — Kungälv, Sweden (enrolling)
- Central Hospital Växjö — Vaxjo, Sweden (enrolling)
Full record on ClinicalTrials.gov
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