Prospective Cohort Study of Response and Tolerability of Accelerated Intermittent Theta-burst Stimulation (1W-AiTBS)
Recruiting · NCT07449338 · Observational (researchers observe without assigning treatment) · Lead sponsor: Vastra Gotaland Region
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
3 locations listed.
- Sahlgrenska University Hospital - Gothenburg, Sweden
- Kungälv Hospital, Kungälv - Kungälv, Sweden
- Central Hospital Växjö - Vaxjo, Sweden