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tVNS, Motivation, and Insulin Sensitivity

RecruitingNAAges 18 Years - 60 YearsAllUniversity of Bonn
NCT07198100 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Disturbances in energy metabolism significantly increase the risk of developing major depressive disorder (MDD), especially in individuals with type 2 diabetes. Insulin sensitivity may particularly impair reward anticipation and motivational processes, contributing to anhedonia, a core symptom of depression. Preclinical and clinical studies highlight the vagus nerve as a critical pathway mediating metabolic signals between the body and the brain, influencing motivational and affective states. The present study aims to evaluate whether acute transcutaneous auricular vagus nerve stimulation (taVNS) improves motivation and mood and whether individual differences in insulin sensitivity modulate these improvements. The investigators plan to recruit 60 patients with MDD and 60 control participants matched for age, sex, and body mass index (BMI), covering a wide BMI range (up to 40 kg/m²) and

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📋 Eligibility rules (as published)
Inclusion criteria: * Participants with depression (DSM-5 diagnosis) or participants without depression (no DSM-5 diagnosis, lifetime) * BMI between 18.5 and 40 kg/m² * Age between 18 and 60 years * Legally valid informed consent Exclusion criteria: The following diagnoses in medical history: * Brain injury * Schizophrenia * Bipolar disorder * Severe substance use disorder * Coronary heart disease * Stroke * Epilepsy * Chronic inflammatory diseases (e.g., rheumatoid arthritis, Crohn's disease, etc.) * Type I diabetes The following diagnoses within 12 months prior to the experiment: * Obsessive-compulsive disorder * Somatic symptom disorder * Eating disorder The following diagnoses in medical history for control participants: * Depression * Anxiety disorders (except specific phobias) Generally: * Contraindications for MRI (e.g., metal implants, claustrophobia) or taVNS (e.g., piercings, sore or diseased skin on the outer right ear) * Pregnant and breastfeeding women will not be included * Unclear capacity to consent * Stomach surgeries affecting body weight (e.g., bypass surgeries)
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What it tests

  • Transcutaneous non-invasive vagus nerve stimulation (tVNS)
  • Sham stimulation
  • Oral glucose tolerance test (oGTT)
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Where

1 site
Section of Medical Psychology, Department of Psychiatry & Psychotherapy, Faculty of Medicine, University of Bonn
Bonn, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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