tVNS and Obesity-related Mechanisms
Launched by UNIVERSITY OF BONN · Apr 29, 2025
Trial Information
Current as of July 27, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
Participants will receive high intensity or low intensity tVNS in a single-blind, randomized, crossover design. Each stimulation (high and low intensity) will be applied over 14 days (effective minimum duration) at home by the participants, with a 7-day (effective minimum duration) washout period in between the conditions. To assess the effect of high (vs. low intensity) stimulation on inflammation and mood/motivation, the investigators plan to use a combination of blood analysis, ecological momentary assessments (EMA), and neuroimaging sessions. To this end, the investigators will apply fu...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Between 18 and 40 years of age
- • BMI between 27 and 35.0 kg/m2
- • Legally valid declaration of consent
- Exclusion Criteria:
- • Current or past diagnosis of brain injury/surgery or neurological condition with permanent effects, epilepsy, stroke, schizophrenia, bipolar disorder, severe substance use disorder, heart disease that precludes use of tVNS, diabetes (type 1 or 2), chronic inflammatory diseases (e.g., rheumatoid arthritis, Crohn's disease, etc.)
- • Following diagnosis within 12 months before start of experiment: obsessive compulsive disorder, somatic symptom disorder, eating disorder
- • Considerable weight change (\>10%) within the last 6 months before the experiment
- • Elevated BMI is due to fat-free mass (e.g., in athletes)
- • Medication or Electroconvulsive therapy to treat a mental, metabolic, or neurological disorder (e.g., selective serotonin reuptake inhibitors, Glucagon-like Peptide-1 agonists) currently or in the last 3 months (hormone treatments that normalize function are not excluded)
- • Anti-inflammatory medication currently or in the last 3 month
- • Contraindications for MRI (e.g., metal implants, claustrophobia)
- • Contraindications for tVNS (e.g., piercings, sore or diseased skin areas on the outer right ear)
- • active implants (e.g., pacemaker), cerebral shunt
- • Pregnant and breastfeeding women
About University Of Bonn
The University of Bonn is a renowned academic institution dedicated to advancing medical research and education. With a strong emphasis on interdisciplinary collaboration, the university engages in cutting-edge clinical trials aimed at improving patient outcomes and advancing healthcare knowledge. Its comprehensive research programs are supported by state-of-the-art facilities and a commitment to ethical standards in clinical practice. By fostering partnerships with healthcare professionals and industry leaders, the University of Bonn plays a pivotal role in translating scientific discoveries into innovative therapeutic solutions.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Bonn, , Germany
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported