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临床试验/NCT04218383
NCT04218383暂停不适用

Effect of Transcranial Direct Current Stimulation (tDCS) Applied Over the Orbitofrontal Cortex on Impulsivity and Decision Making in Obese Subjects

University of Calgary2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年2月3日最近更新:
适应症

试验速览

阶段
不适用
状态
暂停
入组人数
30
试验地点
2
主要终点
Probabilistic Decision Making

研究概览

简要总结

In this study the investigators aim to assess whether transcranial direct current stimulation (tDCS; a safe non-invasive method for modulating the activity of specific brain regions) when applied over the orbitofrontal cortex (OFC) is able to modulate impulsivity in obese participants.

详细描述

In this single-blind, sham controlled study, the investigators will assess whether transcranial direct current stimulation (tDCS; a safe non-invasive method for modulating the activity of specific brain regions) when applied over the orbitofrontal cortex (OFC) is able to modulate impulsivity in obese volunteers. The investigators hypothesize that tDCS applied to the OFC, in comparison to sham tDCS, will significantly reduce impulsivity and enhance decision making as measured by computerized neurocognitive tasks. For this study the investigators will enroll 30 obese individuals aged 18-65 years. Participants will be assessed with a battery of computerized tasks as well as self-reported questionnaires on eating, impulsivity, mood and anxiety. Assessments will be carried out before, during, and after a single 20-minute 2mA tDCS session.

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
Single (Participant)

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

  • Men or Women aged 18 to 65
  • have body mass index of 35 or above
  • have had no recent change in medications in the 2 weeks prior participating in the study
  • able to fast for 4 hours prior participating in the study

排除标准

  • Active Substance use disorder
  • Active Suicidal ideation
  • Psychoactive Medication
  • Past or current Gambling disorder
  • Past or current Anorexia
  • Past or current Bulimia Nervosa
  • Past or current Psychosis
  • Visual impairments preventing performance of the neuropsychological tasks
  • Traumatic Brain Injury
  • Neurological disorder affecting motor functions (Parkinsons, Huntington's, etc)
  • Previous participation in tDCS research/treatment

结局指标

主要结局

Probabilistic Decision Making

时间窗: Before and after a 20-minute tDCS session

Net score of the Iowa Gambling Task The net score ranges from -20 to 30. Higher values represent a better outcome (i.e., enhanced decision-making)

次要结局

  • Food-specific cognitive control(Before and after a 20-minute tDCS session)
  • Cognitive Control(Before and after a 20-minute tDCS session)
  • Delayed discounting(Before and after a 20-minute tDCS session)
  • Motor impulsivity(Before and after a 20-minute tDCS session.)
  • Moderation of effect by self-reported measures of impulsivity and dysregulated eating(Before and after a 20-minute tDCS session.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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