tVNS Effects on Motivation in Depression

November 24, 2021 updated by: University Hospital Tuebingen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • BW
      • Tübingen, BW, Germany, 72076
        • Department of Psychiatry & Psychotherapy, University of Tübingen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Device: transcutaneous 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.
Other Names:
  • transcutaneous auricular vagus nerve stimulation
Device: sham stimulation
Sham procedure for active transcutaneous vagus nerve stimulation
Other Names:
  • transcutaneous stimulation of the earlobe
Experimental: 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).
Device: transcutaneous 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.
Other Names:
  • transcutaneous auricular vagus nerve stimulation
Device: sham stimulation
Sham procedure for active transcutaneous vagus nerve stimulation
Other Names:
  • transcutaneous stimulation of the earlobe
Experimental: 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).
Device: transcutaneous 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.
Other Names:
  • transcutaneous auricular vagus nerve stimulation
Device: sham stimulation
Sham procedure for active transcutaneous vagus nerve stimulation
Other Names:
  • transcutaneous stimulation of the earlobe
Experimental: 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).
Device: transcutaneous 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.
Other Names:
  • transcutaneous auricular vagus nerve stimulation
Device: sham stimulation
Sham procedure for active transcutaneous vagus nerve stimulation
Other Names:
  • transcutaneous stimulation of the earlobe

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
during stimulation (compared to sham)
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)
during stimulation (compared to sham)
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
during stimulation (compared to sham)
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
Pre stimulation and 20 minutes post stimulation (compared to sham)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Collaborators

Universität Tübingen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 11, 2019

Primary Completion (Actual)

January 29, 2021

Study Completion (Actual)

January 29, 2021

Study Registration Dates

First Submitted

October 18, 2021

First Submitted That Met QC Criteria

November 2, 2021

First Posted (Actual)

November 15, 2021

Study Record Updates

Last Update Posted (Actual)

December 8, 2021

Last Update Submitted That Met QC Criteria

November 24, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NBK_TUE004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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