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

Обзор

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.

Вмешательства

• Устройство iTBS (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.

Первичные конечные точки

• Difference in MADRS-S from baseline to six weeks after first iTBS treatment [Срок оценки: 6 weeks]

Вторичные конечные точки (12)

• Difference in MADRS-S from baseline to after last iTBS treatment [Срок оценки: 2 weeks]
• Difference in MADRS-S from baseline to twelve weeks after first iTBS treatment [Срок оценки: 12 weeks]
• Difference in MADRS-S from baseline to six months after first iTBS treatment [Срок оценки: 6 months]
• Difference in SDS from baseline to twelve weeks after first iTBS treatment [Срок оценки: 12 weeks]
• Difference in SDS from baseline to six months after first iTBS treatment [Срок оценки: 6 months]
• Difference in EQ-VAS from baseline to after last iTBS treatment [Срок оценки: 2 weeks]
• Difference in EQ-VAS from baseline to six weeks after first iTBS treatment [Срок оценки: 6 weeks]
• Difference in EQ-VAS from baseline to twelve weeks after first iTBS treatment [Срок оценки: 12 weeks]
• Difference in EQ-VAS from baseline to six months after first iTBS treatment [Срок оценки: 6 months]
• Difference in reported potential side effects from baseline to after last iTBS treatment [Срок оценки: 2 weeks]
• Difference in reported potential side effects from baseline to six weeks after first iTBS treatment [Срок оценки: 6 weeks]
• Difference in reported potential side effects from baseline to twelve weeks after first iTBS treatment [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Швеция · 3 центра

• Sahlgrenska University Hospital — Gothenburg
• Kungälv Hospital, Kungälv — Kungälv
• Central Hospital Växjö — Vaxjo

Идентификаторы

NCT: NCT07449338 · 1W-AiTBS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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