The Effects of Transcutaneous Vagus Nerve Stimulation on Motivation in Major Depressive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 1
- 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
- 是
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
研究组 & 干预措施
Non-depressed control participants: sham first, active taVNS second
Non-depressed control participants receive sham stimulation in the first session (biphasic stimulation with a frequenyc of 25 Hz, 30s OFF/30s ON at the earlobe (sham) for 1.5 h). In a second identical session, they receive active stimulation with the same parameters (at the cymba conchae).
干预措施: transcutaneous vagus nerve stimulation (Device)
Non-depressed control participants: sham first, active taVNS second
Non-depressed control participants receive sham stimulation in the first session (biphasic stimulation with a frequenyc of 25 Hz, 30s OFF/30s ON at the earlobe (sham) for 1.5 h). In a second identical session, they receive active stimulation with the same parameters (at the cymba conchae).
干预措施: sham stimulation (Device)
Patients with major depressive disorders: sham first, active taVNS second
participants with depression receive sham stimulation in the first session (biphasic stimulation with a frequenyc of 25 Hz, 30s OFF/30s ON at the earlobe (sham) for 1.5 h). In a second identical session, they receive active stimulation with the same parameters (at the cymba conchae).
干预措施: transcutaneous vagus nerve stimulation (Device)
Patients with major depressive disorders: sham first, active taVNS second
participants with depression receive sham stimulation in the first session (biphasic stimulation with a frequenyc of 25 Hz, 30s OFF/30s ON at the earlobe (sham) for 1.5 h). In a second identical session, they receive active stimulation with the same parameters (at the cymba conchae).
干预措施: sham stimulation (Device)
Patients with major depressive disorders: active taVNS first, sham second
participants with depression receive active stimulation in the first session (biphasic stimulation with a frequenyc of 25 Hz, 30s OFF/30s ON at the cymba conchae (active) for 1.5 h). In a second identical session, they receive sham stimulation with the same parameters (at the earlobe).
干预措施: transcutaneous vagus nerve stimulation (Device)
Patients with major depressive disorders: active taVNS first, sham second
participants with depression receive active stimulation in the first session (biphasic stimulation with a frequenyc of 25 Hz, 30s OFF/30s ON at the cymba conchae (active) for 1.5 h). In a second identical session, they receive sham stimulation with the same parameters (at the earlobe).
干预措施: sham stimulation (Device)
Non-depressed control participants: active taVNS first, sham second
Non-depressed control participants receive active stimulation in the first session (biphasic stimulation with a frequenyc of 25 Hz, 30s OFF/30s ON at the cymba conchae (active) for 1.5 h). In a second identical session, they receive sham stimulation with the same parameters (at the earlobe).
干预措施: transcutaneous vagus nerve stimulation (Device)
Non-depressed control participants: active taVNS first, sham second
Non-depressed control participants receive active stimulation in the first session (biphasic stimulation with a frequenyc of 25 Hz, 30s OFF/30s ON at the cymba conchae (active) for 1.5 h). In a second identical session, they receive sham stimulation with the same parameters (at the earlobe).
干预措施: sham stimulation (Device)
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