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tVNS and Approach-Avoidance Behavior in Anhedonia and Anxiety

RecruitingNAAges 18 Years - 40 YearsAllDr. Nils B. Kroemer
NCT07476469 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This study investigates if anhedonia and anxiety symptoms are associated with alterations in reinforcement learning, effort trade-offs for wins vs. punishments, and foraging behavior under threat. Moreover, it will investigate whether these processes can be influenced by a metabolic load and/or transcutaneous vagus nerve stimulation (tVNS). The project consists of (a) an online reinforcement learning study, used to characterize learning, reward sensitivity, and meta-cognition, and (b) a laboratory study in which participants first undergo fMRI while completing an effort-based decision-making task. Second, participants will complete two sessions in VR with randomized active or sham tVNS during a foraging task before and after a caloric load with concurrent physiological recordings.

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📋 Eligibility rules (as published)
Inclusion Criteria: * BMI between 18,5 and 30,0 kg/m2, * between 18 and 40 years of age, and * be able and willing to provide informed consent. Exclusion Criteria: * have a high risk of suicide, * have a lifetime diagnosis of severe neurological disorder (incl. ADHD), schizophrenia, bipolar disorder, or severe substance abuse, posttraumatic stress disorder, obsessive-compulsive disorder, diabetes, epilepsy, or coronary heart disease * have fulfilled criteria for an eating disorder or somatic symptom disorder within the last 12-months, * take medication (except psychopharmacological medication for MDD or anxiety), patients have to be on stable psychopharmacological medication for at least two months before study participation (minimizing confounding effects) * contraindications for MRI (metal implants or claustrophobia) * for female individuals if they are pregnant or nursing at the time, * impaired movement ability or hearing * impaired, uncorrected vision (need contact lenses) * contraindications for tVNS hearing aids or diseased skin on the right ear.
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What it tests

  • tVNS
  • Sham
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Where

1 site
University Hospital Bonn, Bonn, Germany
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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