Confirmatory Efficacy Clinical Trial of Amygdala Neurofeedback for Depression

杏仁核神经反馈治疗抑郁症的疗效临床试验

基本信息

批准号：
10633760
负责人：
Kym Young
金额：
$ 74.42万
依托单位：
UNIVERSITY OF PITTSBURGH AT PITTSBURGH
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-06-01 至 2028-05-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10633760
关键词：
Adopted Affect Alexithymias Amygdaloid structure Anhedonia Antidepressive Agents Autobiography Brain Brain region Clinical Clinical Trials Communities Control Groups Data Diagnosis Disease Dissemination and Implementation Double-Blind Method Emotional Ensure Evaluation Feedback Functional Magnetic Resonance Imaging Gender Goals Individual Intervention Literature Major Depressive Disorder Measures Mediating Memory Mental Depression Outcome Participant Patient Self-Report Patients Pharmaceutical Preparations Phase Process Provider Proxy Public Health Quality of life Randomized Recovery Rest Sampling Scientist Series Signal Transduction Specificity Stimulus Symptoms Time Training Translational Research Treatment Efficacy Work clinical effect clinically relevant confirmatory clinical trial confirmatory trial depressive symptoms design efficacy evaluation experimental group follow-up future implementation hemodynamics implementation determinants improved indexing intervention refinement memory recall neurofeedback novel therapeutics pharmacologic process evaluation psychologic public health relevance randomized, clinical trials reduce symptoms response stakeholder perspectives success symptomatic improvement treatment response

项目摘要

Abstract Up to two-thirds of patients diagnosed with major depressive disorder (MDD) will not respond to standard pharmacological and psychological interventions, suggesting a need to develop novel therapeutics. Decreased reactivity to positive stimuli, indexed by low amygdala reactivity to positive autobiographical memory recall, may be a causal mechanism interfering with recovery from MDD. Previous work suggests that individuals who do respond to antidepressant medications show increased amygdala activity to positive stimuli that is indistinguishable from controls, while those who do not respond fail to show this increase in amygdala activity. In several small studies we have shown that MDD participants are able to increase their amygdala response during positive memory recall via real-time fMRI neurofeedback (rtfMRI-nf) training, and that this increase is associated with large and rapid reductions in depressive symptoms. Here, we propose to evaluate the efficacy of this intervention in a large-scale confirmatory R01 clinical trial. N=200 MDD individuals will be randomly assigned under double-blind conditions to the amygdala rtfMRI-nf intervention or to a control rtfMRI-nf intervention where they receive yoked sham neurofeedback (instead of their own brain activity they see the signal from another participant who underwent amygdala rtfMRI-nf). We propose to use the same neurofeedback paradigm as our prior studies, with one critical difference. Rather than using a control condition that involves training another brain region, we will adopt a yoked sham control group in order to demonstrate that our findings are robust to the type of control condition used. We additionally aim to determine whether we can use self-report mechanisms to assess who might need the proposed neurofeedback intervention and whether they are likely to be successful in using it. Finally, we will work with implementation scientists to obtain feedback from end-users and clinicians to understand contextual influences on outcomes and increase intervention acceptability. Success will confirm a new non-pharmacological, non-invasive intervention for MDD individuals.

抽象的多达三分之二的被诊断患有重度抑郁症 (MDD) 的患者对标准没有反应药理和心理干预，表明需要开发新的疗法。减少对积极刺激的反应，以杏仁核对积极自传体记忆回忆的反应性低为指标，可能是干扰 MDD 康复的因果机制。先前的工作表明，个人对抗抑郁药物有反应显示杏仁核对积极刺激的活动增加与对照组没有区别，而那些没有反应的人则没有表现出杏仁核活动的增加。在几项小型研究中，我们表明 MDD 参与者能够增强杏仁核反应在通过实时功能磁共振成像神经反馈（rtfMRI-nf）训练进行积极记忆回忆期间，这种增加是与抑郁症状的大幅快速减轻有关。在这里，我们建议评估功效大规模验证性 R01 临床试验中的这种干预措施。 N=200个MDD个体将被随机抽取在双盲条件下分配至杏仁核 rtfMRI-nf 干预或对照 rtfMRI-nf 他们接受假神经反馈（而不是他们自己的大脑活动）的干预来自另一位接受杏仁核 rtfMRI-nf 的参与者的信号）。我们建议使用相同的神经反馈范式与我们之前的研究一样，有一个关键的区别。而不是使用控制条件这涉及到训练另一个大脑区域，我们将采用一个假对照组来证明我们的研究结果对于所使用的控制条件类型是稳健的。我们还旨在确定我们是否可以使用自我报告机制来评估谁可能需要建议的神经反馈干预，并且他们是否有可能成功使用它。最后，我们将与实施科学家合作，获得来自最终用户和临床医生的反馈，以了解对结果的背景影响并增加干预的可接受性。成功将证实一种新的非药物、非侵入性干预MDD的方法个人。