tVNS and Approach-Avoidance Behavior in Anhedonia and Anxiety
Recruiting · NCT07476469 · Interventional (participants receive a specific treatment) · Lead sponsor: Dr. Nils B. Kroemer
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 is running
2 locations listed.
- University Hospital Bonn, Bonn, Germany - Bonn, Germany
- University Hospital Bonn, Bonn, Germany - Bonn, Germany