Investigating the Effect of the Intensity of Primary Motor Cortex Cathodal TDCS on Appetite; a Double-blind Sham-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Change in the subjective rating of appetite
研究概览
简要总结
This is a randomized double-blind sham controlled systematic investigation to understand the importance of the brain region that controls the tongue and the submental muscle region on perceived appetite. The results of this study can have clinical implications for a phenomenon called hyperphagia.
详细描述
After explaning all the procedure and the scientific aims of the project to participants and completing the informed consent form, each participant will be randomly asked to take part in the experiment while fasting for at least 6 hours or completely sated, to enable an investigation of the role of the basic level of hunger on the effects of brain stimulation on subjective appetite. Different intensities of stimulation (1 mA, 1.5 mA, and sham) will be used in three separate groups, to which participants will be randomly assigned, in a double-blind manner.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Normal weight, based on the Body Mass Index (BMI)
- •Males and females between 18 and 35
排除标准
- •Use of psychoactive drugs
- •Presence of metal implants in the brain, skull, scalp or neck
- •Use of pacemaker
- •Neurological or psychiatric pathologies
- •History of severe head injury
- •Pregnancy
- •Clinical obesity based on BMI
研究组 & 干预措施
1 mA tDCS
Participants receive the stimulation with an intensity of 1 mA.
干预措施: 1 mA tDCS (Device)
1.5 mA tDCS
Participants receive the stimulation with an intensity of 1.5 mA.
干预措施: 1.5 mA tDCS (Device)
Sham tDCS
Participants receive the sham stimulation (zero electric current after a short initial increase).
干预措施: Sham tDCS (Device)
结局指标
主要结局
Change in the subjective rating of appetite
时间窗: Baseline measurement in the begninning of the experiment before stimulation versus post stimulation, exactly after the stimulation protocol has finished (with an approximate time interval of 1 hour)
A visual analogue scale (VAS; from 0 meaning not hungry at all, to 100 meaning extremely hungry), will be used to record the perceived level of hunger before and after the stimulation to enable evaluation of the effects of stimulation on perceived appetite.
次要结局
- Change in excitability of the submental muscle region in primary motor cortex(Baseline measurement in the begninning of the experiment before stimulation versus post stimulation, exactly after the stimulation protocol has finished (with an approximate time interval of 1 hour))
研究者
Abed Hadipour Lakmehsari
Principal Investigator
University of Messina