Responsive Neurostimulation for Loss of Control Eating

响应性神经刺激治疗饮食失控

• 批准号: 9892043
• 负责人: Casey Harrison Halpern
• 金额: $ 128.12万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-03-15 至 2021-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9892043
• 关键词: Affect; Algorithmic Software; Algorithms; Attenuated; Awareness; Behavior; Behavioral; Binge Eating; Biological Markers; Brain; Brain region; Clinic; Clinical; Clinical Trials; Collaborations; Computer software; Corpus striatum structure; Data; Detection; Devices; Disease; Eating; Eating Behavior; Eating Disorders; Electric Stimulation; Electrophysiology (science); Esthesia; Exposure to; FDA approved; Fatty acid glycerol esters; Feasibility Studies; Feedback; Feeding Patterns; Food; Frequencies; Goals; Home environment; Human; Implant; Implanted Electrodes; In Situ; Individual; Institutional Review Boards; Intervention; Investigation; Laboratories; Lead; Measures; Mediating; Methods; Monitor; Mus; Neurosurgeon; Nucleus Accumbens; Obesity; Palate; Participant; Patients; Positioning Attribute; Property; Protocols documentation; Refractory; Reporting; Rewards; Safety; Scientist; Signal Transduction; Social Behavior; Specificity; Stimulus; System; Telemetry; Testing; Therapeutic; TimeLine; Universities; Update; Wireless Technology; aggressive therapy; bariatric surgery; brain circuitry; candidate marker; cohort; design; effective therapy; feeding; human subject; improved; interest; loss of control over eating; meetings; multidisciplinary; multimodality; neuroimaging; neuropsychiatric disorder; novel; pre-clinical; prevent; programs; prototype; recruit; response; safety and feasibility; safety testing

Project Abstract Background/Description. Given our mutual interest in direct brain stimulation as an effective treatment for non-adherent eating disorders associated with refractory obesity, our multidisciplinary team at Stanford University has developed a collaboration with NeuroPace, Inc, a company that recently received FDA approval for a responsive neurostimulator. We previously found that electrically stimulating the nucleus accumbens (NAc) of mice attenuates binge-like eating. In addition, increased power in low frequency oscillations appears to temporally correlate with anticipation of food reward and predict the onset of a binge. There is increasing awareness that obese individuals frequently lose control over food, which leads to binge-like eating. We hypothesize that a responsive neurostimulator could be used to identify low frequency oscillations that represent loss of control over eating and deliver responsive stimulation to the NAc to prevent a binge. Objective. To test stimulation parameters and detection algorithms for responsive neurostimulation in humans in an Early Feasibility Study. Methods. All needed regulatory avenues will be pursued, and an Early Feasibility Study will be performed in human subjects with refractory obesity due to loss of control eating. We will primarily assess device function and safety, but will utilize multimodal controlled and ambulatory measures to test the potential of this clinical program for LOC eating in obesity.

项目摘要