Mindfulness Engaged Neurostimulation for Depression
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in EEG source localized pDMN alpha activity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Medi1-TBS
This arm will receive a multimodal treatment with a digital mindfulness training focused on attention to breathing for up to 10 min session dose for up to 20 sessions combined with neuro-navigated iTBS type of rTMS (for 20 treatments over 4 weeks) targeting the left dorsolateral prefrontal cortex (DLPFC) brain region.
干预措施: Medi-TBS (Combination Product)
Medi3-TBS
This arm will receive a multimodal treatment with a digital mindfulness training focused on intermittent deep breathing for up to 10 min session dose for up to 20 sessions combined with neuro-navigated iTBS type of rTMS (for 20 treatments over 4 weeks) targeting the left dorsolateral prefrontal cortex (DLPFC) brain region.
干预措施: Medi-TBS (Combination Product)
结局指标
主要结局
Change in EEG source localized pDMN alpha activity
时间窗: 4 weeks
EEG alpha band (8-12 Hz) activity source-localized to the posterior Default Mode Network (pDMN) brain region extracted on distracted trials of the Breath Attention Assessment of Mindfulness task serves as the primary neural target.
次要结局
- Change in Montgomery Åsberg Depression Rating Scale Scores (MADRS)(8 weeks)
- Change in Selective Attention(4 weeks)
- Change in Flanker Inhibition(4 weeks)
研究者
Jyoti Mishra
Associate Professor
University of California, San Diego