Neurofeedback During Eating: A Novel Mechanistic Treatment for Bulimia Nervosa
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Functional near-infrared spectroscopy (fNIRS)-measured neural activation and connectivity
研究概览
简要总结
The purpose of this study is to examine the effects of noninvasive prefrontal cortex (PFC) neurofeedback during eating in women with bulimia nervosa (BN) using a wearable brain imaging device, functional near-infrared spectroscopy (fNIRS). The investigators will examine how this training may influence inhibitory control and BN symptoms.
详细描述
The purpose of this study is to examine the effects of PFC neurofeedback during eating in women with bulimia nervosa (BN) using fNIRS. Specifically, the study aims 1) to demonstrate ventrolateral PFC (vlPFC) neurofeedback target engagement in women with BN using fNIRS; and 2) to link changes in PFC activation to changes in inhibitory control and eating-related symptoms.
Data will be collected from women with BN who will be randomly assigned to one of two group conditions (real or sham-control neurofeedback during eating). Participation includes a phone screening assessment, psychodiagnostic assessment, one in-person evaluation, one neurofeedback session, behavioral tasks, online questionnaires before and after the neurofeedback session, and a remote follow-up assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to 45 years
- •Meet diagnostic criteria for bulimia nervosa
- •Current body mass index greater than or equal to 18.5kg/m2 but under 30kg/m2
- •English-speaking
排除标准
- •Ongoing medical treatment, major medical condition, or psychiatric disorder that may interfere with study variables or participation
- •Current psychotherapy focused primarily on eating disorder symptoms
- •Pregnancy or planned pregnancy, or lactation during the study period
- •Allergy to ingredients in the standardized meal or in the shake
研究组 & 干预措施
Real fNIRS Neurofeedback Arm
Participants assigned to the experimental arm will see their true, real-time brain activation (i.e., active real-time neurofeedback) during the neurofeedback session. This activation will be displayed to the participant as a thermometer that will increase as brain activation in the target region increases.
干预措施: Real fNIRS Neurofeedback (Other)
Sham-Control fNIRS Neurofeedback Arm
Participants assigned to the sham-control arm will see false feedback (or a fake signal) that is not connected to their right vlPFC activation during the neurofeedback session.
干预措施: Sham-Control fNIRS Neurofeedback (Other)
结局指标
主要结局
Functional near-infrared spectroscopy (fNIRS)-measured neural activation and connectivity
时间窗: approximately 1 hour
The investigators will evaluate changes in PFC neural activation and connectivity as a function of neurofeedback.
Number of loss-of-control eating and purging episodes
时间窗: 2 weeks
Frequency of loss-of-control eating and purging episodes. Participants will self-report on how often loss-of-control eating and purging episodes occur using electronic daily diaries in the week before and the week after the neurofeedback session.
Go/no-go task performance
时间窗: 2 weeks
Participants will complete a go/no-go task 1 week before and 1 week after the neurofeedback session to measure inhibitory control. Participants behavioral performance on the go/no-go task will be determined by the percentage of incorrect responses made as they are prompted to react to different pictorial stimuli. Participants' percentages of error can range from 0% to 100%. A higher percentage indicates a lower behavioral performance on the task.
Severity of loss-of-control eating scale
时间窗: 2 weeks
Severity of loss-of-control eating. Participants will rate the severity of their feelings of control over eating and purging episodes on a Likert-type scale from 0-10. Higher score indicates greater severity of loss of control.
次要结局
未报告次要终点
研究者
Laura Berner
Assistant Professor
Icahn School of Medicine at Mount Sinai