Status:
ENROLLING_BY_INVITATION
tVNS and Obesity-related Mechanisms
Lead Sponsor:
University of Bonn
Conditions:
Overweight/Obesity (BMI: 27 and 35 kg/m2)
Eligibility:
All Genders
18-40 years
Phase:
NA
Brief Summary
The overarching goal of the project is to assess whether transcutaneous Vagus Nerve Stimulation (tVNS) induced reduction of central and peripheral inflammation is associated with tVNS induced changes ...
Detailed Description
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 minimu...
Eligibility Criteria
Inclusion
- Between 18 and 40 years of age
- BMI between 27 and 35.0 kg/m2
- Legally valid declaration of consent
Exclusion
- 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
Key Trial Info
Start Date :
April 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06954844
Start Date
April 8 2025
End Date
March 31 2027
Last Update
May 2 2025
Active Locations (1)
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1
Section of Medical Psychology, Department of Psychiatry & Psychotherapy, Faculty of Medicine, University of Bonn
Bonn, Germany, 53127