Theta Burst Stimulation With an 8-Coil Versus H1-Coil for Resistant Depression

Официальное название

Randomized Controlled Trial of Two Accelerated Transcranial Magnetic Stimulation Methods in the Treatment of Resistant Depression: Intermittent Theta Burst Stimulation With an 8-Coil Versus H1-Coil

Обзор

The goal of this clinical trial is to compare response rates after treatment with Figure Eight-Coil TMS versus H-Coil TMS on the prefrontal cortex left dorsolateral, in patients suffering from depression resistant. The main question it aims to answer is: rTBS (accelerated neuronavigated intermittent Theta Burst Stimulation) is more effective than hTBS (accelerated deep intermittent Theta Burst Stimulation) in the treatment of resistant depression in terms of response rate.? Researchers will compare Figure Eight-Coil TMS (rTBS) versus H-Coil TMS (hTBS) to see if rTBS is more effective than hTBS. Participants will: * Receive, for each stimulation method, 8 sessions per day spaced 50 minutes apart, over 5 days. * Have visit all day of stimulation for checkups and tests. * Have a a research MRI before and after treatment. * Have follow-up visits at 1 month, 2 months, 3 months, 6 months, and 12 months post-treatment, via teleconsultation.

Вмешательства

• Устройство repetitive transcranial magnetic stimulation
  A burst of 3 pulses sent at a frequency of 50 Hz, repeated with a frequency of 5 Hz for 2 seconds, followed by an 8-second pause. This sequence is repeated for 59 cycles, totaling 9 minutes and 50 seconds, with a total of 1800 pulses.

Первичные конечные точки

• The response rate according to the MADRS scale [Срок оценки: Before the treatment and after the treatment at 5 day.]

Вторичные конечные точки (12)

• Clinical improvement of treatment-resistant depression [Срок оценки: Before the treatment and after the treatment at 5 days.]
• Clinical improvement of treatment-resistant depression [Срок оценки: Before the treatment and after the treatment at 5 days.]
• Clinical improvement of treatment-resistant depression [Срок оценки: Before the treatment and after the treatment at 5 days.]
• Clinical improvement of treatment-resistant depression [Срок оценки: Before the treatment and after the treatment at 5 days.]
• Tolerance to treatment [Срок оценки: Each visits of clinical trial : each day of treatment (5 days), at 1 month, 2 month, 3 month, 6 month and 12 month.]
• Improvement of cognitive functions. [Срок оценки: Before the treatment and after the treatment at 5 day.]
• Improvement of cognitive functions. [Срок оценки: Before the treatment and after the treatment at 5 day.]
• Improvement of cognitive functions. [Срок оценки: Before the treatment and after the treatment at 5 day.]
• Improvement of cognitive functions. [Срок оценки: Before the treatment and after the treatment at 5 day.]
• Improvement of cognitive functions. [Срок оценки: Before the treatment and after the treatment at 5 day.]
• Improvement of cognitive functions. [Срок оценки: Before the treatment and after the treatment at 5 day.]
• Improvement of cognitive functions. [Срок оценки: Before the treatment and after the treatment at 5 day.]

Критерии участия

Критерии включения

• Patients over 18 years of age
• Presenting a major depressive episode according to the DSM-5-TR criteria, occurring as part of major depressive disorder (unipolar depression)
• The major depressive episode must meet the criteria for treatment resistance, defined by a lack of response to at least two different antidepressant treatments prescribed at an effective dose for a duration of 6 weeks or more
• Stable treatment for at least 6 weeks
• Affiliation with a social security system or State Medical Assistance (Aide Médicale d'État)
• Patient agrees to participate in the study and has signed an informed consent form

Критерии исключения

• Presence of a contraindication to TMS: epilepsy, intracranial foreign body, cochlear implant, retinal implant, pacemaker
• Presence of a bipolar disorder according to DSM-5-TR criteria
• Presence of catatonic or psychotic features during the current episode
• Presence of severe psychiatric disorders other than a major depressive episode
• Presence of neurological disorders
• Unstable epilepsy
• Current moderate to severe addiction disorders other than caffeine and/or tobacco
• Current suicidal ideation
• Use of any brain stimulation treatment (ECT, rTMS, tDCS) for the current episode
• Pregnancy or breastfeeding
• Women of childbearing potential without effective contraception
• Persons under guardianship or legal protection

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

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06813313 · 2024-A00954-43

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗