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tVNS Effects on Motivation in Depression

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05120336
Enrollment
67
Registered
2021-11-15
Start date
2019-12-11
Completion date
2021-01-29
Last updated
2021-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder

Keywords

vagus nerve stimulation, food reward, anhedonia, vigor, reward learning, mood

Brief summary

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.

Interventions

DEVICEtranscutaneous vagus nerve stimulation

Non-invasive brain stimulation technique that is used to stimulate vagal afferent projections to the nucleus of the solitary tract. Invasive VNS has been approved for the treatment of treatment-resistant depression.

DEVICEsham stimulation

Sham procedure for active transcutaneous vagus nerve stimulation

Sponsors

Universität Tübingen
CollaboratorOTHER
University Hospital Tuebingen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* 30 kg/m\^2 \> BMI \> 18.5 kg/m\^2

Exclusion criteria

lifetime * brain injury * coronary heart disease and occurred apoplexy * schizophrenia * bipolar disorder * implants (e.g., cochlea implant) * asthma 12 month * severe substance use disorders (DSM-V), except tobacco * obessive compulsive disorder * somatic symptom disorder * eating disorder

Design outcomes

Primary

MeasureTime frameDescription
Food reward ratingsduring stimulation (compared to sham)Operationalized via visual analogue scale ratings of liking \[-100 - 100\] and wanting \[0-100\] in a food cue reactivity task
Motivation to work for rewards: frequency of button presses to gain food an monetary rewardsduring 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)
Reward learning: correct choicesduring stimulation (compared to sham)Operationalized via number of correct value-based choices in a valenced go/no-go learning task
Positive and negative moodPre stimulation and 20 minutes post stimulation (compared to sham)Operationalized via visual analogue ratings (0-100) of positive and negative affect schedule mood items

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026