Real-time Neurofeedback Regulating Brain Cognitive Function in Obese Individuals: a Near-infrared Spectroscopy-based Study.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change of Body Mass Index
研究概览
简要总结
To determine the efficacy of real-time fNIRS neurofeedback for regulating the brain cognitive function in obese individuals.
详细描述
In the current study, 60 obese subjects will be recruited, and they were randomly classified into the group who will receive real neurofeedback and the group who will receive sham neurofeedback. Participants will receive the real-time neurofeedback for 12 times, 3 to 4 times a week, each time the real-time neurofeedback consists of 12 sessions of liftstone as the index reflecting the brain activity. Sham group will receive the identical neurofeedback.
All of the subjects will undergo magnetic resonance imaging scan, during which T1, diffusion tensor imaging, resting-state, and task fMRI data will be collected. For task Fmri scan, the participants will be asked to finish four cognitive task, including 2-Back working memory, Go/No-Go task, Willingness to Pay for Food, and Delay Discounting tasks. Clinical measurements including BMI, eating behavior, psychiatric status will be assessed. Those aforementioned examinations will be performed at before the neurofeedback, 6th times and the end of the treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- 是
入选标准
- •Body mass index (BMI) ≥ 25
- •18 to 65 years old
- •No severe mental disorders(depression; schizophrenia; bipolar disorder; etc.).
排除标准
- •Severe dysfunction of heart, liver, kidney and hematopoietic system
- •Substance addiction
- •Patients who cannot be treated with fMRI or fNRIS neurofeedback
- •Those who take other weight loss drugs.
研究组 & 干预措施
NIRS group
Participants with obesity, 12 sessions of NIRS feedback
干预措施: NIRS neurofeedback (Behavioral)
Sham NIRS group
Participants with obesity, 12 sessions of sham NIRS feedback
干预措施: Sham NIRS neurofeedback (Behavioral)
Healthy control group
Healthy participants, 12 sessions of NIRS feedback
干预措施: NIRS neurofeedback (Behavioral)
结局指标
主要结局
Change of Body Mass Index
时间窗: Baseline, through study completion, an average of 6 weeks
Change of the degree of obesity and health of the body
次要结局
- Working Memory(Baseline, through study completion, an average of 6 weeks)
- Change of Result of Willingness to Pay for Food(Baseline, through study completion, an average of 6 weeks)
- Change of Result of Go/No-Go(Baseline, through study completion, an average of 6 weeks)
研究者
Wu Wenjun-1
Clinical physician
Xijing Hospital