tVNS Effects on Motivation in Depression

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05120336
• Other study ID #: NBK_TUE004
• Status: Completed
• Phase: N/A
• Start date: December 11, 2019
• Est. completion date: January 29, 2021

Study information

• Verified date: October 2021
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: January 29, 2021
• Est. primary completion date: January 29, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

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.
• sham stimulation
Sham procedure for active transcutaneous vagus nerve stimulation

Locations

Country	Name	City	State
Germany	Department of Psychiatry & Psychotherapy, University of Tübingen	Tübingen	BW

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Tuebingen	Universität Tübingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Food reward ratings	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)
Primary	Motivation to work for rewards: frequency of button presses to gain food an monetary rewards	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)
Primary	Reward learning: correct choices	Operationalized via number of correct value-based choices in a valenced go/no-go learning task	during stimulation (compared to sham)
Primary	Positive and negative mood	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)