VGR Accelerated TMS Treatment for Depression

Официальное название

Vastra Gotaland Region Accelerated Transcranial Magnetic Stimulation Treatment for Depression

Обзор

Intermittent theta burst stimulation (iTBS), a variant of repetitive transcranial magnetic stimulation (rTMS), is a well documented method for treatment of depression. The aim of the study is to assess the effect of an accelerated iTBS protocol compared to a routine iTBS protocol. In the accelerated protocol patients will receive 1200 pulses per session (2 sessions per day, 15 treatment days) and in the routine protocol patients will receive 600 pulses per session (1 session per day, 30 treatment days). Participants (n = 146) will be recruited among patients referred to iTBS and randomized to treatment. Participants will be assessed by a psychiatrist, or a resident psychiatrist, prior to treatment to assure that they fulfill all inclusion criteria and non of the exclusion criteria. A psychiatrist, or a resident psychiatrist, will assess depressive symptoms 3 and 6 weeks after first day of treatment. Patients will complete self-rating questionnaires during screening, weekly for 6 weeks starting from the first day of treatment, and 6 months after end 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 three weeks after first iTBS treatment [Срок оценки: 3 weeks]

Вторичные конечные точки (12)

• Difference in MADRS-S from baseline to one week after first iTBS treatment [Срок оценки: 1 week]
• Difference in MADRS-S from baseline to two weeks after first iTBS treatment [Срок оценки: 2 weeks]
• Difference in MADRS-S from baseline to four weeks after first iTBS treatment [Срок оценки: 4 weeks]
• Difference in MADRS-S from baseline to five weeks after first iTBS treatment [Срок оценки: 5 weeks]
• Difference in MADRS-S from baseline to six weeks after first iTBS treatment [Срок оценки: 6 weeks]
• Difference in MADRS-S from baseline to six months after last iTBS treatment [Срок оценки: 6 months]
• Difference in QIDS-SR from baseline to one week after first iTBS treatment [Срок оценки: 1 week]
• Difference in QIDS-SR from baseline to two weeks after first iTBS treatment [Срок оценки: 2 weeks]
• Difference in QIDS-SR from baseline to three weeks after first iTBS treatment [Срок оценки: 3 weeks]
• Difference in QIDS-SR from baseline to four weeks after first iTBS treatment [Срок оценки: 4 weeks]
• Difference in QIDS-SR from baseline to five weeks after first iTBS treatment [Срок оценки: 5 weeks]
• Difference in QIDS-SR from baseline to six weeks after first iTBS treatment [Срок оценки: 6 weeks]

Критерии участия

Критерии включения

• diagnosis of depression verified through a Mini International Neuropsychiatric Interview (M.I.N.I.)
• MADRS-S >= 20
• unchanged medication last month
• unchanged psychological treatment last month
• admitted to psychiatric ward last month
• no ECT or TMS last six months
• provision of signed informed consent form
• indication for TMS is depression

Критерии исключения

• addiction (illicit drugs or alcohol)
• pregnancy
• epilepsy
• 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
• regular use of benzodiazepines
• 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

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Швеция · 2 центра

• Kungälv Hospital — Kungälv
• Hospital of Skövde — Skövde

Идентификаторы

NCT: NCT06138678 · VAiT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗