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临床试验/NCT02717247
NCT02717247终止不适用

Effect of Transcranial Random Noise Stimulation of Prefrontal Cortex on Craving Supply Subject Suffering From Obesity

Hôpital le Vinatier2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2016年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
13
试验地点
2
主要终点
Effects on craving frequencies

研究概览

简要总结

Obesity is worldwide a public health problem. According to World Health Organization (WHO), overweight and obesity are the fifth death risk factor worldwide. At least 2.8 million adults die each year. Food addiction is one of the causes of obesity that may benefit from new therapeutic options.

详细描述

Transcranial random noise stimulation is a noninvasive brain stimulation technic. The modulation of the electrical activity of the right and left dorsolateral prefrontal cortex (DLPFC) by tRNS is able to act on the phenomenon of craving in other addictions. This allows us to make the assumption that tRNS stimulation could constitute a treatment for food addiction especially in obesity.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
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

入选标准

  • Female or male between 18 and 65 years old
  • Patients suffering from obesity, with a BMI ≥
  • Food dependence score at the Yale Food addiction Scale ≥ 3

排除标准

  • Presence of a an other psychiatric diagnosis of Axis I (DSM IV);
  • Presence of addictive comorbidity other than food addiction
  • Psychotropic treatment;
  • Pregnancy or lactation;
  • Contraindication to fMRI .

结局指标

主要结局

Effects on craving frequencies

时间窗: Change from baseline after 3 months

by questionnaires scores and declarative number of food

次要结局

  • change in biological markers such as lipid profile, ghrelin, leptin, prolactin(Change from baseline after 3 months)
  • change in body weight(Change from baseline after 3 months)
  • change in waist circumference(Change from baseline after 3 months)
  • change in body mass index(Change from baseline after 3 months)

研究者

发起方
Hôpital le Vinatier
申办方类型
Other
责任方
Sponsor

研究点 (2)

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