tVNS Effects on Motivation in Depression

NCT ID: NCT05120336

Last Updated: 2021-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-11
• Study Completion Date: 2021-01-29

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

transcutaneous vagus nerve stimulation

Intervention Type: 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.

sham stimulation

Intervention Type: DEVICE

Sham procedure for active transcutaneous vagus nerve stimulation

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).

Group Type: EXPERIMENTAL

transcutaneous vagus nerve stimulation

Intervention Type: 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.

sham stimulation

Intervention Type: DEVICE

Sham procedure for active transcutaneous vagus nerve stimulation

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).

Group Type: EXPERIMENTAL

transcutaneous vagus nerve stimulation

Intervention Type: 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.

sham stimulation

Intervention Type: DEVICE

Sham procedure for active transcutaneous vagus nerve stimulation

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).

Group Type: EXPERIMENTAL

transcutaneous vagus nerve stimulation

Intervention Type: 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.

sham stimulation

Intervention Type: DEVICE

Sham procedure for active transcutaneous vagus nerve stimulation

Interventions

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.

Intervention Type: DEVICE

sham stimulation

Sham procedure for active transcutaneous vagus nerve stimulation

Intervention Type: DEVICE

Other Intervention Names

transcutaneous auricular vagus nerve stimulation; transcutaneous stimulation of the earlobe

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universität Tübingen

OTHER

Sponsor Role: collaborator

University Hospital Tuebingen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Psychiatry & Psychotherapy, University of Tübingen

Tübingen, Baden-Wurttemberg, Germany

Countries

Germany

Other Identifiers

NBK_TUE004

Identifier Type: -

Identifier Source: org_study_id