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临床试验/NCT05120336
NCT05120336已完成不适用

The Effects of Transcutaneous Vagus Nerve Stimulation on Motivation in Major Depressive Disorder

University Hospital Tuebingen2 个研究点 分布在 1 个国家目标入组 67 人开始时间: 2019年12月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
67
试验地点
2
主要终点
Motivation to work for rewards: frequency of button presses to gain food an monetary rewards

研究概览

简要总结

Attaining goals or rewards commonly entails response costs. In light of cost and benefits, how do participants decide what effort should be put in to give it a shot? Figuratively, you may "go with your gut", but the literal contribution of the gut-brain axis in allocating effort is poorly understood to date. Here, the investigators propose to investigate non-invasive transcutaneous vagal nerve stimulation (tVNS) as a potential modulator of energy metabolism and response vigor. Since the neural mechanisms causing the diverse cognitive and behavioral effects of the stimulation remain largely elusive, the investigators will use computational modeling of instrumental behavior and determine the primary metabolic effects of the stimulation. The investigators hypothesize that tVNS will lead to activation of afferent targets in the brain. In turn, the elicited brain activation is expected to mediate the cognitive effects of the stimulation. This may affect both sides of the utility equation because anti-depressive effects may correspond to boosting the benefit of effort whereas anti-nociceptive effects may reduce perceived costs of effort. Collectively, dissecting the cognitive effects of non-invasive tVNS in healthy individuals may facilitate the more widespread use as a treatment in mental disorders that are characterized by metabolic alterations such as depression.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
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

  • 30 kg/m^2 > BMI > 18.5 kg/m^2

排除标准

  • brain injury
  • coronary heart disease and occurred apoplexy
  • schizophrenia
  • bipolar disorder
  • implants (e.g., cochlea implant)
  • severe substance use disorders (DSM-V), except tobacco
  • obessive compulsive disorder
  • somatic symptom disorder
  • eating disorder

结局指标

主要结局

Motivation to work for rewards: frequency of button presses to gain food an monetary rewards

时间窗: during stimulation (compared to sham)

Operationalized via the relative frequency of button presses on an Xbox controller in an effort allocation task during either the first seconds of each trial (invigoration) or each complete trial (maintenance)

Food reward ratings

时间窗: during stimulation (compared to sham)

Operationalized via visual analogue scale ratings of liking \[-100 - 100\] and wanting \[0-100\] in a food cue reactivity task

Reward learning: correct choices

时间窗: during stimulation (compared to sham)

Operationalized via number of correct value-based choices in a valenced go/no-go learning task

Positive and negative mood

时间窗: Pre stimulation and 20 minutes post stimulation (compared to sham)

Operationalized via visual analogue ratings (0-100) of positive and negative affect schedule mood items

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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