Validation of a Novel Cerebellar-striatal Satiety Circuit in Humans
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 4
- 主要终点
- Change in BOLD response in the ventral striatum
研究概览
简要总结
This study uses a noninvasive technique called transcranial magnetic stimulation (TMS) to study satiety in healthy individuals.
TMS is a noninvasive way of stimulating the brain, using a magnetic field to change activity in the brain. The magnetic field is produced by a coil that is held next to the scalp. In this study, the investigators will be stimulating the brain to learn more about the role of the cerebellum in satiety.
详细描述
The purpose of this study is to conduct a circuit manipulation experiment to test the hypothesis that targeting the cerebellum can alter activity in response to food cues to advance the understanding of the involvement of the cerebellar-striatal circuit in feeding behavior.
Participants will undergo an initial screening session to complete informed consent and undergo baseline assessments including physical activity and food craving. Participants will additionally undergo an MRI scan that includes structural and resting-state functional magnetic resonance imaging (rsfMRI). These rsfMRI imagines will be used to isolate individual resting state networks for targeting of rTMS modulation.
Participants will then complete two separate testing sessions involving MRI imaging and food intake assessments before and after rTMS. One visit will involve consumption of a filling meal; the other visit will be completed following an overnight fast.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Healthy individuals aged 18 to 65
- •BMI of 20-35.0 kg/m2
- •Normal or corrected-to-normal vision
- •Good general health
- •Ability to understand and willingness to sign written informed consent document
排除标准
- •Current and/or past medical conditions
- •Current and/or past eating disorder
- •On a restricted diet and/or taking weight loss medication(s)
- •History of bariatric surgery
- •Weight fluctuation >3% in past 3 months
- •Recent history of illicit recreational drug abuse
- •Current nicotine use
- •Intellectual disability
- •Conditions that might result in increased risks of side effects or complications from TMS or MRI
结局指标
主要结局
Change in BOLD response in the ventral striatum
时间窗: 30 minutes pre-TMS and 30 minutes post-TMS, at each of two main study visits (fed, fasted)
Change in functional activation of the ventral striatum will be assessed before (pre-TMS) and after (post-rTMS) rTMS stimulation, measured separately at the fed visit and at the fasted visit.
Change in BOLD response in the cerebellum
时间窗: 30 minutes pre-TMS and 30 minutes post-TMS, at each of two main study visits (fed, fasted)
Change in functional activation of the cerebellum will be assessed before (pre-TMS) and after (post-rTMS) rTMS stimulation, measured separately at the fed visit and at the fasted visit.
Ad libitum snack food intake
时间窗: baseline, up to 60 minutes post-TMS at each of two main study visits (fed, fasted)
Change in total caloric intake during the ad libitum snack food session will be assessed at the baseline visit and after (post-rTMS) rTMS stimulation, the latter measured separately at the fed visit and at the fasted visit.
Change in food reward valuation
时间窗: up to 60 minutes pre-TMS and up to 60 minutes post-TMS, at each of two main study visits (fed, fasted)
Change in food reward valuation of high-calorie foods will be assessed using the Willingness to Pay task, measured before (pre-TMS) and after (post-rTMS) rTMS stimulation, measured separately at the fed visit and at the fasted visit.
次要结局
未报告次要终点
研究者
Laura M Holsen
Associate Professor of Psychiatry
Brigham and Women's Hospital