Transcutaneous vagus nerve stimulation to shift approach–avoidance behavior in people with anxiety and anhedonia
Official title: Vagus Nerve Stimulation and Approach-Avoidance Behavior in Anhedonia and Anxiety
Run by University of Bonn · NCT07476469 · Data updated 2026-11-12
This project tests whether non-invasive ear vagus nerve stimulation (tVNS), before and after a small meal, can change decision-making and foraging under threat in adults with high anxiety and/or high anhedonia and in healthy volunteers.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 40 Years |
| Sex | All |
| Enrollment | 104 (estimated) |
| Sponsor | University of Bonn Academic / other |
| Locations | 1 site (Bonn) |
| Status | Recruiting |
| Started | March 23, 2026 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2028 |
| Registry record updated | April 23, 2026 |
| Trial ID | NCT07476469 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–40 with BMI 18.5–30 kg/m² who can provide consent, undergo MRI and VR procedures, and have either high anxiety symptoms, high anhedonia symptoms, both, or are healthy controls are the intended participants.
✕Probably not a fit
People with severe neurological disorders, bipolar disorder, schizophrenia, recent eating disorders, certain cardiovascular or metabolic conditions, pregnancy, MRI contraindications, or impaired movement, hearing, or uncorrected vision are not eligible and unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The work combines an online reinforcement-learning task, MRI-based phenotyping, and in-lab virtual reality to probe how anxiety and anhedonia affect learning, effort trade-offs, and foraging under threat. After online screening and diagnostic visits, participants undergo fMRI while performing an effort-based decision task, then complete two randomized VR sessions with active or sham tVNS both when hungry and after a standardized ~400 kcal milkshake. Physiological signals such as heart rate are recorded while participants freely move in VR so behavioral adaptations and recovery can be measured. Groups include healthy controls and participants with high anxiety, high anhedonia, or both, matched for age, sex, and BMI.
Why it matters
Potential benefit: If successful, this could point to a non-drug way to rebalance approach and avoidance behaviors and potentially improve functioning in people with anxiety or anhedonia.
How similar studies have gone: Previous small studies have shown that tVNS can influence mood, learning, and autonomic function, but combining tVNS with VR foraging and a metabolic manipulation in anxiety/anhedonia is a relatively novel approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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University Hospital Bonn, Bonn, Germany
Bonn, Germany Recruiting
Study contacts
- Study coordinator: Dr. Anne Kühnel
- Email: akuehnel@uni-bonn.de
- Phone: +49 228 28711519
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.