tVNS Effects on Motivation in Depression

NCT05120336 | Completed

• 1 other identifier: NBK_TUE004
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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)

• 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)

• 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)

• 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)

Study Arms (4)

Non-depressed control participants: sham first, active taVNS second

EXPERIMENTAL

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; Device: sham stimulation

Patients with major depressive disorders: sham first, active taVNS second

EXPERIMENTAL

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; Device: sham stimulation

Patients with major depressive disorders: active taVNS first, sham second

EXPERIMENTAL

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; Device: sham stimulation

Non-depressed control participants: active taVNS first, sham second

EXPERIMENTAL

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; Device: sham stimulation

Interventions

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.

Also known as: transcutaneous auricular vagus nerve stimulation

Non-depressed control participants: active taVNS first, sham second; Non-depressed control participants: sham first, active taVNS second; Patients with major depressive disorders: active taVNS first, sham second; Patients with major depressive disorders: sham first, active taVNS second

sham stimulation DEVICE

Sham procedure for active transcutaneous vagus nerve stimulation

Also known as: transcutaneous stimulation of the earlobe

Non-depressed control participants: active taVNS first, sham second; Non-depressed control participants: sham first, active taVNS second; Patients with major depressive disorders: active taVNS first, sham second; Patients with major depressive disorders: sham first, active taVNS second

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• kg/m\^2 \> BMI \> 18.5 kg/m\^2

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Tuebingen: lead
• Universität Tübingen: collaborator

Study Sites (1)

Department of Psychiatry & Psychotherapy, University of Tübingen

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Anhedonia

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2021
• First Posted: November 15, 2021
• Study Start: December 11, 2019
• Primary Completion: January 29, 2021
• Study Completion: January 29, 2021
• Last Updated: December 8, 2021

Record last verified: 2021-10

Locations

DE (1)