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OpenTrials
Completed

NCT Number: NCT05120336

tVNS Effects on Motivation in Depression

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.

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Key information

Conditions

Major Depressive Disorder Anhedonia Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Psychiatry & Psychotherapy, University of Tübingen

Tübingen, Baden-Wurttemberg, 72076, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcutaneous vagus nerve stimulation

Device

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.

Other names: transcutaneous auricular vagus nerve stimulation

Sham stimulation

Device

Sham procedure for active transcutaneous vagus nerve stimulation

Other names: transcutaneous stimulation of the earlobe

Primary outcomes

  1. Food reward ratings

    Time frame: 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

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

    Time frame: 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)

  3. Reward learning: correct choices

    Time frame: during stimulation (compared to sham)

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

  4. Positive and negative mood

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Collaborators

  • Universität Tübingen

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 15, 2021
Registry last updated
Dec 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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