By InvitationNot Applicable

tVNS and Obesity-related Mechanisms

Germany60 participantsStarted 2025-04-08

Plain-language 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 in mood and motivation in a sample of healthy participants with overweight and obesity.

Who can participate

Age range18 Years – 40 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Stimulation-induced mid-term changes in a multiplex panel of different inflammatory biomarkers (peripheral inflammation)

Timeframe: Baseline, immediately after the first 14-day stimulation phase and before a 7-day washout, immediately after the second 14-day stimulation phase

Stimulation-induced mid-term changes in circulating immune cells (peripheral inflammation)

Timeframe: Baseline, immediately after the first 14-day stimulation phase and before a 7-day washout, immediately after the second 14-day stimulation phase

Stimulation-induced mid-term changes in tissue edema as assessed using non-restricted fraction (isotropic DBSI-NRF (f(D), D = 0.3 - 3.0 μm2/ms))

Timeframe: Baseline, immediately after the first 14-day stimulation phase and before a 7-day washout, immediately after the second 14-day stimulation phase

Stimulation-induced mid-term changes in tissue cellularity as assessed using restricted fraction (isotropic DBSI-RF (f(D), D ≤ 0.3 μm2/ms))

Timeframe: Baseline, immediately after the first 14-day stimulation phase and before a 7-day washout, immediately after the second 14-day stimulation phase

Stimulation-induced mid-term changes in PANAS items (mood)

Timeframe: Baseline (immediately before each stimulation phase), immediately after the first 14-day stimulation phase and before a 7-day washout, immediately after the second 14-day stimulation phase

Trial details

NCT IDNCT06954844

SponsorUniversity of Bonn

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-03-31

View on ClinicalTrials.gov More Overweight/Obesity (BMI: 27 and 35 kg/m2) trials