Mindfulness Engaged Neurostimulation for Depression (MEND II)

Официальное название

Mindfulness Engaged Neurostimulation for Depression

Обзор

Repetitive Transcranial Magnetic stimulation (rTMS) is an FDA-approved therapy for treatment resistant depression (TRD) that involves brief magnetic stimulation pulses on the dorsolateral prefrontal cortex (DLPFC) brain region. But studies of rTMS alone show remission rates of \~30%. Additionally, rTMS has not been shown to improve cognitive functioning that may be an independent factor predicting treatment success. This study will develop a novel multimodal treatment, which combines intermittent theta burst stimulation (iTBS) - a type of rTMS with digital mindfulness training to engage brain plasticity, enhance cognition and alleviate depression symptoms in individuals with TRD.

Подробное описание

This study aims to develop a novel multimodal treatment for treatment resistant depression (TRD), which combines intermittent theta burst stimulation (iTBS), a type of FDA-approved rTMS protocol, with digital mindfulness training. We propose that this multimodal treatment will suppress posterior Default Mode Network (pDMN) brain activity as measured with electroencephalography (primary outcome and neural target), as well as enhance cognition and alleviate depression symptoms in patients with TRD (secondary outcomes). The study will conduct a two-arm randomized controlled trial to demonstrate neural target engagement by the multimodal iTBS + digital mindfulness training relative to an active control training combined with iTBS.

Вмешательства

• Комбинированный продукт Medi-TBS
  The multimodal intervention involves combining FDA-approved repetitive transcranial magnetic stimulation (rTMS) with digital mindfulness exercises.

Первичные конечные точки

• Change in EEG source localized pDMN alpha activity [Срок оценки: 4 weeks]

Вторичные конечные точки (3)

• Change in Selective Attention [Срок оценки: 4 weeks]
• Change in Flanker Inhibition [Срок оценки: 4 weeks]
• Change in Montgomery Åsberg Depression Rating Scale Scores (MADRS) [Срок оценки: 8 weeks]

Критерии участия

Критерии включения

• Diagnosis of major depressive episode (MDE, in accordance with the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5), in the context of unipolar major depressive disorder.
• At least one failed antidepressant medication trial at level 3 in the Antidepressant -Treatment History Form: Short Form (ATHF-SF) classification.
• Montgomery-Åsberg Depression Rating Scale (MADRS) Score >19 (moderate - severe depression).
• No increase or initiation of new antidepressant therapy in the four weeks prior to screening.
• Demonstrated capacity to give informed consent.

Критерии исключения

• Inability to provide informed consent.
• Medically unstable patients.
• Concomitant neurological disorder or a history of a seizure disorder.
• Exhibiting current suicidal behavior rating on the Columbia Suicide Severity Rating Scale (C-SSRS)
• Patients who are pregnant or breastfeeding.
• Any psychotic disorder or current active psychotic symptoms.
• Patients who have intracranial implants, other medical device or condition deemed unsafe for TMS.
• Contraindication to MRI scanning.

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

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• UC San Diego Health Psychiatry — San Diego

Идентификаторы

NCT: NCT07512284 · MEND II

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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