Stanford-Matter Neuroscience High-Resolution fMRI Advanced Neurofeedback Feasibility Trial (fMRI Neurofeedback) Medical
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Determine the safety and efficacy of neurofeedback for treating depression through MADRS scale changes
研究概览
简要总结
Study will utilize an app, Matter Neuroscience, designed to help users with depression understand positive emotions and the neurotransmitters that create them. We hope to learn the safety and efficacy of neurofeedback for treating depression and lay the groundwork for a pivotal clinical trial.
详细描述
The Matter Neuroscience application, available through the Apple App Store, is designed to help users understand positive emotions and the neurotransmitters that create them. The application allows users to collect good moments by adding photos and other information to the application and activating positive emotions when the photos and other information are viewed. When positive emotions are activated, the application allows users to quickly rate the positive emotions felt during moments. The data collected is translated into the user's Matter Score. Tracking the user's Matter Score can allow them to see how they are doing from the inside out. Neurotransmitter activity helps build neuroplasticity in the brain. Higher levels of neuroplasticity correlate with higher levels of creativity, intelligence, and empathy as well as longer, healthier, happier lifespans. The 7TMRI Scanner will be used to gather structural and functional brain data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female, between the ages of 18 and 80 at the time of screening.
- •Primary diagnosis of nonpsychotic major depressive disorder (MDD) without a history of psychotic features.
- •Score on the MADRS scale between 15-25
- •Able to read, understand, and provide written, dated informed consent prior to screening. Proficiency in English sufficient to complete questionnaires / follow instructions during fMRI. Stated willingness to comply with all study procedures, including availability for the duration of the study, and to communicate with study personnel about adverse events and other clinically important information.
- •Must possess an iPhone with the latest iOS version compatible with the app or must be willing to use a loaner iPhone from the study if available.
- •Has had at least one lifetime antidepressant treatment failure (ATHF)
- •The dose of the primary antidepressant medication (if applicable) must be stable for 4 weeks prior to baseline, and participants must agree to continue at this dose throughout the study period.
- •In good general health, as evidenced by medical history and determined by study physician
- •For women of reproductive potential: agree to the use of highly effective contraception during study participation.
- •Adequate visual acuity (with or without corrective lenses) to view study materials while in the MRI.
- •Agreement to adhere to Lifestyle Considerations throughout study duration.
排除标准
- •Contraindication to MRI (ferromagnetic metal in their body)
- •Severe claustrophobia
- •Women that are pregnant or breastfeeding or with a positive urine pregnancy test at participation, or who are planning to become pregnant during the study period.
- •Primary psychiatric condition other than MDD requiring treatment except stable comorbid anxiety disorder
- •History of or current psychotic disorder, schizophrenia, psychosis, bipolar disorder, or severe borderline personality disorder.
- •Diagnosis of intellectual disability, autism spectrum disorder, or other neurodevelopmental disorder.
- •Current moderate or severe substance use disorder or demonstrating signs of acute substance withdrawal
- •Urine screening test positive for recent use of recreational drugs except for marijuana..
- •Considered at significant risk for suicide during the course of the study.
- •Recent (within 4 weeks of any clinical effect) or concurrent use of rapid acting antidepressant agent (i.e., a course of ECT or TMS). Excluding ketamine.
- •History of significant neurologic disease, including dementia, Parkinson's or Huntington's disease, brain tumor, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma as determined by the PD.
- •Untreated or insufficiently treated endocrine or metabolic disorder.
- •Any other condition deemed by the PD to interfere with the study or increase risk to the participant
- •Alexithymia as determined by the Toronto Alexithymia Scale
- •Treatment with an investigational drug or other intervention within the study period.
- •Not currently in a major depressive episode as defined by the MINI.
- •More than 5 lifetime adequate antidepressant medication failures (ATHF).
研究组 & 干预措施
Arm 1B. No home training no neurofeedback, repeated scans, personal photos
No home training no neurofeedback, repeated scans, personal photos
干预措施: Personal Photos (Other)
Arm 1A. No home training, no neurofeedback, no photos, no repeated scans
No home training, no neurofeedback, no photos, no repeated scans
Arm 1B. No home training no neurofeedback, repeated scans, personal photos
No home training no neurofeedback, repeated scans, personal photos
干预措施: Matter Neuroscience App (Device)
Arm 1B. No home training no neurofeedback, repeated scans, personal photos
No home training no neurofeedback, repeated scans, personal photos
干预措施: No Home Training (Other)
Arm 2. No home training, neurofeedback, stock photos, repeated scans
No home training, neurofeedback, stock photos, repeated scans
干预措施: No Home Training (Other)
Arm 2. No home training, neurofeedback, stock photos, repeated scans
No home training, neurofeedback, stock photos, repeated scans
干预措施: Matter Neuroscience App (Device)
Arm 2. No home training, neurofeedback, stock photos, repeated scans
No home training, neurofeedback, stock photos, repeated scans
干预措施: Stock Photos (Other)
Arm 3. No home training, neurofeedback, personal photos, repeated scans
No home training, neurofeedback, personal photos, repeated scans
干预措施: Matter Neuroscience App (Device)
Arm 3. No home training, neurofeedback, personal photos, repeated scans
No home training, neurofeedback, personal photos, repeated scans
干预措施: No Home Training (Other)
Arm 3. No home training, neurofeedback, personal photos, repeated scans
No home training, neurofeedback, personal photos, repeated scans
干预措施: Personal Photos (Other)
Arm 4. Home training, no neurofeedback, stock photos, repeated scans
Home training, no neurofeedback, stock photos, repeated scans
干预措施: Matter Neuroscience App (Device)
Arm 4. Home training, no neurofeedback, stock photos, repeated scans
Home training, no neurofeedback, stock photos, repeated scans
干预措施: Stock Photos (Other)
Arm 4. Home training, no neurofeedback, stock photos, repeated scans
Home training, no neurofeedback, stock photos, repeated scans
干预措施: Home Training (Other)
Arm 5. Home training, neurofeedback, stock photos, repeated scans
Home training, neurofeedback, stock photos, repeated scans
干预措施: Matter Neuroscience App (Device)
Arm 5. Home training, neurofeedback, stock photos, repeated scans
Home training, neurofeedback, stock photos, repeated scans
干预措施: Stock Photos (Other)
Arm 5. Home training, neurofeedback, stock photos, repeated scans
Home training, neurofeedback, stock photos, repeated scans
干预措施: Home Training (Other)
Arm 6. Home training, no neurofeedback, personal photos, repeated scans
Home training, no neurofeedback, personal photos, repeated scans
干预措施: Matter Neuroscience App (Device)
Arm 6. Home training, no neurofeedback, personal photos, repeated scans
Home training, no neurofeedback, personal photos, repeated scans
干预措施: Personal Photos (Other)
Arm 6. Home training, no neurofeedback, personal photos, repeated scans
Home training, no neurofeedback, personal photos, repeated scans
干预措施: Home Training (Other)
Arm 7. Home training, neurofeedback, personal photos, repeated scans
Home training, neurofeedback, personal photos, repeated scans
干预措施: Matter Neuroscience App (Device)
Arm 7. Home training, neurofeedback, personal photos, repeated scans
Home training, neurofeedback, personal photos, repeated scans
干预措施: Personal Photos (Other)
Arm 7. Home training, neurofeedback, personal photos, repeated scans
Home training, neurofeedback, personal photos, repeated scans
干预措施: Home Training (Other)
结局指标
主要结局
Determine the safety and efficacy of neurofeedback for treating depression through MADRS scale changes
时间窗: Screening, Baseline, Immediate Post, One Month Post, Optional Three Month and Optional Six Month
Determine the safety and efficacy of neurofeedback for treating depression through MADRS (Montgomery-Åsberg Depression Rating Scale) scale changes. The 9-item self-report version of the MADRS has an overall score range from 0-27, with higher scores corresponding to higher levels of depression.
次要结局
- Measure fMRI Change(Baseline, Week 2, Week 4, Week 6, Immediate Post, Optional Three Month Post Scan)
研究者
David Spiegel
Professor and Associate Chair of Psychiatry & Behavioral Sciences
Stanford University