Transcranial Direct Current Stimulation (tDCS) with Cognitive Training to Reduce Impulsivity and Weight in Veterans with Obesity: A Clinical Trial

经颅直流电刺激 (tDCS) 结合认知训练可减少肥胖退伍军人的冲动和体重：一项临床试验

• 批准号: 10576261
• 负责人: SHALAMAR D SIBLEY
• 金额: --
• 依托单位: MINNEAPOLIS VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-04-01 至 2026-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10576261
• 关键词: Anodes; Appetite Regulation; Bariatrics; Behavior; Behavior Therapy; Behavioral; Body Weight decreased; Brain; Cathodes; Cephalic; Characteristics; Chronic Disease; Clinic; Clinical; Clinical Trials; Combined Modality Therapy; Coupled; Coupling; Data; Decision Making; Devices; Disease; Double-blind trial; Eating; Eating Disorders; Enrollment; Executive Dysfunction; Exercise; Gambling; Gatekeeping; Group Structure; Habits; Health; Impulsive Behavior; Impulsivity; Individual; Intervention; Left; Life Style; Link; Measurable; Medical; Modality; Neuronal Plasticity; Non obese; Obesity; Outcome; Outcome Measure; Participant; Personality Traits; Pilot Projects; Population; Prefrontal Cortex; Protocols documentation; Randomized; Reaction Time; Recording of previous events; Refractory; Reporting; Research Personnel; Risk; Safety; Structure; Substance abuse problem; Task Performances; Testing; Therapeutic; Training; Training and Education; Veterans; Visit; Weight; analog; behavior change; cognitive training; computerized; design; executive function; follow-up; improved; interest; loss of control over eating; member; neuroregulation; noninvasive brain stimulation; novel; obesity treatment; pandemic disease; primary outcome; programs; randomized trial; recruit; success; transcranial direct current stimulation; weight loss program; weight maintenance

Impulsivity has been implicated in refractory obesity in bariatric and non-bariatric subjects (Sutin 2011, Filbey 2017, Gunstad 2017, Galioto 2016, Benard 2017). A healthy prefrontal cortex (PFC) may mitigate excess impulsivity effects on appetite regulation by providing critical executive function as a gate-keeper. Galioto et al found that executive function predicts weight loss success in structured medical weight loss programs (Galioto 2016). Given this background, improving prefrontal executive function to mitigate impulsivity would be valuable in obesity treatment. Cognitive training for improvement of executive function has not shown sufficient therapeutic promise. Similarly, transcranial direct current stimulation (tDCS), a noninvasive neuromodulation modality, aimed at the PFC has been shown to be safe and well tolerated but not sufficiently effective as monotherapy. Combining prefrontal neuromodulation with cognitive training may be the novel, effective way forward for prefrontal neuromodulation as obesity therapy. Together, the two modalities enhanced executive function in non-obese subjects with executive function deficits in studies done by members of our team (Gilmore 2018). Thirty subjects with a clinical history of impulsive behavior were recruited for a sham-controlled protocol coupling the balloon analog risk task, a decision-making test, with five consecutive days of 25-minute tDCS treatments in which a 2-mA constant current was delivered over the dorsolateral PFC, anode over right PFC and cathode over the left PFC. Active tDCS stimulation coupled with cognitive training improved Balloon Analog Risk Task performance and reduced impulsivity on the Barratt Impulsiveness Scale. Reduction in risky decision making generalized to a second risk-related decision-making task, the Risk Task, which had not been utilized during the stimulated training sessions. Reduction in risky decision making persisted at the final two month follow up visit. This evidence supports our hypothesis that tDCS coupled with brain training can enhance executive function and improve clinical outcomes in individuals who suffer from impulsivity-related conditions. Neuroplasticity-based interventions such as this may provide novel treatment approaches to the challenging clinical problem of obesity. We have assembled a team of investigators with combined obesity and neuromodulation expertise to conduct a randomized double-blind trial of active vs. sham tDCS combined with cognitive training in subjects with obesity who report out-of-control eating and are enrolling in a structured group lifestyle coaching program. We will determine if tDCS coupled with cognitive training decreases impulsivity in these individuals with obesity. Our second aim is to evaluate whether tDCS coupled with executive function training enhances weight loss.

冲动与肥胖和非肥胖受试者的难治性肥胖有关（Sutin 2011， Filbey 2017，Gunstad 2017，Galioto 2016，Benard 2017）。健康的前额叶皮层（PFC）可以减轻 过度冲动通过提供关键的执行功能作为看门人来影响食欲调节。 Galioto等人发现，在结构化医学减肥中，执行功能预测减肥成功 程序（Galioto 2016）。在这种背景下，改善前额叶执行功能以减轻冲动 对肥胖症的治疗很有价值认知训练改善执行功能尚未显示 足够的治疗承诺。同样，经颅直流电刺激（tDCS），一种非侵入性的 针对PFC的神经调节方式已被证明是安全的，耐受性良好，但还不够 作为单一疗法有效。 将前额叶神经调节与认知训练相结合可能是一种新颖有效的方法 前额神经调节作为肥胖症治疗。这两种模式共同增强了执行功能， 在我们团队成员进行的研究中，有执行功能缺陷的非肥胖受试者（Gilmore 2018）。 招募了30名有冲动行为临床史的受试者进行假对照研究 将气球模拟风险任务（决策测试）与连续5天的25分钟tDCS相结合 治疗中，在背外侧PFC上输送2 mA恒定电流，阳极在右侧PFC上 积极的tDCS刺激结合认知训练改善了球囊 模拟风险任务表现和Barratt冲动量表上的冲动性降低。降低风险 决策一般化到第二个风险相关的决策任务，风险任务，这是没有 在模拟训练期间使用。在最后两个阶段，风险决策的减少持续存在 一个月随访。这一证据支持了我们的假设，即tDCS与大脑训练相结合， 增强执行功能，改善患有冲动相关疾病的患者的临床结局 条件基于神经可塑性的干预，如这可能提供新的治疗方法， 肥胖的临床难题。 我们已经组建了一个研究团队，他们拥有肥胖和神经调节方面的专业知识， 在受试者中进行一项活性与假tDCS联合认知训练的随机双盲试验 报告饮食失控的肥胖症患者，正在参加一个结构化的团体生活方式指导计划。 我们将确定tDCS与认知训练相结合是否会降低这些个体的冲动性， 肥胖我们的第二个目标是评估tDCS与执行功能训练相结合是否会增加体重 损失