RecruitingNCT07449338

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


Sponsor

Vastra Gotaland Region

Enrollment

36 participants

Start Date

Mar 1, 2026

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria5

  • 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

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Interventions

DEVICEiTBS (intermittent theta-burst stimulation)

The iTBS treatment is a type of rTMS (repetitive transcranial magnetic stimulation), delivered with MagPro R30 stimulator and a conventional cool-B65 coil. The iTBS treatment is applied to over the dorsolateral prefrontal cortex using a standardized measuring of the anatomical landmark F3 from the 10-20 positioning system. The coil is positioned with the handle at in a 45 degree angle from the midline. The centre of the butterfly is placed towards the patient head.


Locations(3)

Sahlgrenska University Hospital

Gothenburg, Sweden

Kungälv Hospital, Kungälv

Kungälv, Sweden

Central Hospital Växjö

Vaxjo, Sweden

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NCT07449338


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