Cognitive Process-based Real-time fMRI Neurofeedback in MDD and Rumination
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Changes in Brooding subscale of Ruminative Responses Scale (RRS) scores
研究概览
简要总结
The purpose of this study is to assess the feasibility and efficacy of real-time fMRI neurofeedback for rumination.
详细描述
Neuroimaging MRI techniques for measuring brain structure, tissue composition, and Blood Oxygenation Level Dependent functional Magnetic Resonance imaging (BOLD fMRI) will be used to measure task-dependent and task-independent brain hemodynamic and electrophysiological changes in human subjects with major depressive disorders (MDD).
After being informed about the study and potential risks, all participants giving written informed consent will undergo one session of the cognitive process-based fMRI neurofeedback (CNF) targeting the rumination-related brain functional connectivity, and a one-week follow-up. Participants will be randomized in a double-blind manner (participant and investigator) in a 1:1 ratio to Active (receiving feedback from their own brain activity) or Sham (receiving artificially generated feedback).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, 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
- •Good general health
- •DSM-5 diagnosis of major depressive disorder (MDD)
排除标准
- •General Exclusion Criteria:
- •Pregnancy
- •Medical Conditions:
- •Moderate to severe traumatic brain injury (>30 min. loss of consciousness or >24 hours posttraumatic amnesia) or other neurocognitive disorder with evidence of neurological deficits.
- •Presence of co-morbid medical conditions not limited to but including cardiovascular (e.g., history of acute coronary event, stroke) and neurological diseases (e.g., Parkinson's disease), as well as pain disorders.
- •Presence of an uncontrolled medical condition that is deemed by the investigators to interfere with the proposed study procedures, or to put the study participant at undue risk.
- •Psychiatric Disorders:
- •Current severe suicidal ideation or attempt within the past 12 months.
- •Psychosis
- •Bipolar disorder
- •Substance abuse or dependence within the previous 6 months
- •Contraindications for MRI:
- •Bodily implants of unsafe paramagnetic materials such as pace-makers and aneurysm clips.
- •Claustrophobia that is severe enough to preclude MRI scanning.
- •Medications:
- •Evidence of recreational drug use from a urine test.
结局指标
主要结局
Changes in Brooding subscale of Ruminative Responses Scale (RRS) scores
时间窗: Through study completion (average: 2 weeks)
The RRS Brooding subscale is a self-report scale to measure brooding ruminative responses. A higher score indicates higher brooding ruminative responses with a maximum score of 20 and a minimum score of 5.
Functional connectivity change between precuneus and right temporoparietal junction (rTPJ)
时间窗: Through study completion (average: 2 weeks)
Functional connectivity between precuneus and rTPJ will be calculated and evaluated using fMRI BOLD percent signal change.
次要结局
- Changes in sum of Brooding and Depression subscales of Ruminative Responses Scale (RRS) scores(Through study completion (average: 2 weeks))
- Changes in total score of Ruminative Responses Scale (RRS) scores(Through study completion (average: 2 weeks))
- Changes in Depression subscale of Ruminative Responses Scale (RRS) scores(Through study completion (average: 2 weeks))
- Changes in Reflection subscale of Ruminative Responses Scale (RRS) scores(Through study completion (average: 2 weeks))