NCT07449338 Prospective Cohort Study of Response and Tolerability of Accelerated Intermittent Theta-burst Stimulation (1W-AiTBS)
| NCT ID | NCT07449338 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Vastra Gotaland Region |
| Condition | Depression |
| Study Type | OBSERVATIONAL |
| Enrollment | 36 participants |
| Start Date | 2026-03-01 |
| Primary Completion | 2027-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 36 participants in total. It began in 2026-03-01 with a primary completion date of 2027-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07449338 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Depression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07449338 currently recruiting?
Yes, NCT07449338 is actively recruiting participants. Contact the research team at melker.hagsater@vgregion.se for enrollment information.
Where is the NCT07449338 trial being conducted?
This trial is being conducted at Gothenburg, Sweden, Kungälv, Sweden, Vaxjo, Sweden.
Who is sponsoring the NCT07449338 clinical trial?
NCT07449338 is sponsored by Vastra Gotaland Region. The trial plans to enroll 36 participants.
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