CNS Modification of Food Craving by Neurofeedback
试验速览
- 阶段
- 不适用
- 入组人数
- 5
- 主要终点
- Increase brain activity in frontal brain areas
研究概览
简要总结
The investigators plan to evaluate H.E.G. (Hematoencephalography) modality in brain modulation of appetite and food craving in a randomized controlled study. The H.E.G. will serve as the neurofeedback modality while the functional brain imaging will enable assessment and hopefully validation of changes brain activity related to food craving and self-control. H.E.G. is a relatively new neurofeedback technique which similar to fMRI, is based on changes in blood oxygenation level as a result of regional brain activation. The unique advantage of this technology regarding our enterprise is that it inheritably samples the two brain areas that are in our focus of interest: the superior orbito-frontal cortex (OFC) which Involved in self-control and reward processing, and the anterior cingulate cortex (ACC) which processes cognitive and emotional information. The investigators will combine HRV (Heart rate variability) biofeedback, which is a well-established treatment form in the investigators therapeutic sessions and will correlate functional neuroimaging with behavioral, anthropometric and laboratory data.
The intervention name is: Measurements of blood flow changes within the brain and online visual feedback to the participant by a H.E.R. (Hematoencephalography) N.I,R (Near Infra Red sensor) sensor made by MindMedia, The Netherlands and a NEXUX4 Hardware, Bluetooth unit, Bio Trace Plus software made by MindMedia, The Netherlands.
Hypothesis: The neurofeedback practice sessions are expected to facilitate improved control of blood flow to frontal brain areas, as a marker of brain activity in these areas
详细描述
CNS Modification of Food Craving by Neurofeedback Study Protocol Research Plan and Methodology
The investigators's goal is to modulate food craving and eating behavior among overweight and obese participants using and interventional neurofeedback program. During the study period, each participant will go through 10 neurofeedback sessions, two sessions per week, over a five-week period. In addition, each participant will go through two functional MRI sessions, the first session, before the neurofeedback intervention, to document baseline neurocognitive response to food stimuli using a specified paradigm and the second - after completion of the neurofeedback series, in order to evaluate changes in C.N.S. response to food.
Subjects: 6 overweight and obese participants will be participate in our pilot study and will go through 2 fMRI sessions, 10 H.E.G. sessions and 3 anthropometric and metabolic evaluations during one year intervention and follow-up.
Study Design: In the investigators's single arm pilot study participants will go through a series of neurofeedback sessions with psychological, anthropomorphic, and laboratory evaluation taken before and after intervention.
Baseline questioners: Baseline assessment will include completion of a combined questionnaire that will address a spectrum eating behavior traits, including hunger and craving, addiction, impulsivity, binge eating, addiction, impulsivity, hedonic eating and externally driven eating14-23.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Right handed BMI in the range of 28-35kg/m2
排除标准
- •Current or past history of any major psychiatric disorder
- •Major medical or neurological disorders
- •Exposure to drugs likely to influence cerebral blood flow or neurological function within 3 weeks
- •History of drug or alcohol abuse
- •General MRI exclusion criteria
结局指标
主要结局
Increase brain activity in frontal brain areas
时间窗: 7 weeks
次要结局
- Behavioural measures(12 months)
- Anthropometric measures(12 months)
- Number of participants with adverse events(12 months)
- Increased activation of superior frontal brain regions and middle temporal regions in response to food stimuli, in the second fMRI session, perforemed after the neurofeedback sessions, compared to baseline session(7 weeks)
研究者
Dr. Ruth Perchik
Dr.
Sheba Medical Center