NCT05120336

tVNS Effects on Motivation in Depression

Completed NA Last updated 8 December 2021

What this trial tests

NA trial testing transcutaneous vagus nerve stimulation in Major Depressive Disorder in 67 participants. Completed in 29 January 2021.

Timeline

11 December 2019

Primary endpoint
29 January 2021

29 January 2021

Quick facts

Lead sponsor	University Hospital Tuebingen
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	basic science
Enrollment	67
Start date	11 December 2019
Primary completion	29 January 2021
Estimated completion	29 January 2021
Sites	1 location across Germany

Drugs / interventions tested

• transcutaneous vagus nerve stimulation
• sham stimulation

Conditions studied

• Major Depressive Disorder — all drugs for Major Depressive Disorder →

Sponsor

University Hospital Tuebingen

Who can join

Adults 18 to 65, any sex, with Major Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.