Auricular Vagus Stimulation in Obesity

August 26, 2025 updated by: National Medical Research Center for Therapy and Preventive Medicine

The Effectiveness of Transcutaneous Electrical Nerve Stimulation of the Auricular Branch of the Vagus Nerve in Loss Weight and Improving the Quality of Life in Patients With Obesity

Transcutaneous vagus nerve stimulation (TENS) involves stimulation of the left and/or right auricular branch of the vagus nerve with low-frequency electrical impulses. In recent years, the possibilities of using this technology in chronic conditions characterized by immune and metabolic dysregulation have been studied. The aim of this study is to investigate the effectiveness of TENS in reducing weight and improving quality of life in patients with various degrees of obesity.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Obesity is one of the leading causes of disability and death worldwide. In 2016, more than 1.9 billion adults were overweight, according to the World Health Organization. According to current projections, by 2030, 60% of the world's population (that is, 3.3 billion people) may be overweight (2.2 billion) or obese (1.1 billion), if trends in obesity continue.

In 2021, the journal Nature Communications published data on the effectiveness of the use of an invasive device that stimulates the efferent fibers of the vagus nerve of the stomach with light fluxes and thereby reduces the severity of hunger. In addition, in small clinical trials in patients with depression and epilepsy treated with transcutaneous vagus nerve stimulation, this procedure has been shown to lead to significant weight loss.

Although the mechanisms are not fully understood, it is believed that a high-calorie diet contributes to the desensitization of the vagus afferent fibers to peripheral signals and leads to a decrease in the constitutive expression of orexigenic receptors and neuropeptides. Violation of signal transmission along the afferent fibers of the vagus nerve may be sufficient for the development of hyperphagia and obesity, and stimulation of the vagus nerve, respectively, can be used in the treatment of these conditions. Recent discoveries revealed a new and important role of the vagus nerve within a physiological mechanism that utilizes afferent and efferent signaling in controlling cytokine levels and inflammation - the inflammatory reflex.

Afferent vagus nerve projections to the GI tract and the hepatic portal system play a major role in communicating alterations in peripheral metabolic homeostasis, including changes in cholecystokinin, lipids, leptin, insulin and glucose levels to the brain. In a reflex manner, efferent vagus nerve innervations of the heart, liver and pancreas provide cardio-metabolic regulatory output. Cholecystokinin- and leptin-induced afferent vagus nerve activity importantly mediates satiety and regulates feeding behavior. Cholecystokinin, released as a result of intestinal lipid accumulation also causes activation of afferent signaling and subsequent efferent vagus nerve output to liver that suppresses hepatic gluconeogenesis.

Transcutaneous vagus nerve stimulation (TENS) involves the stimulation of the left and/or right auricular branch of the vagus nerve in the area of the cymba concha with low-frequency electrical impulses. The auricular branch of the vagus nerve runs superficially, which makes it a favorable target for non-invasive stimulation techniques to modulate vagal activity. It gained popularity due to minimal side effects and low cost.

In recent years, the use of this technology in the treatment of various disorders, including headache, tinnitus, prosocial behavior, atrial fibrillation, associative memory, schizophrenia, traumatic pain, and Crohn's disease, has been explored - chronic conditions characterized by immune and metabolic dysregulation. For this reason, there have been many early-stage clinical trials on a diverse range of conditions. These trials often report conflicting results for the same indication.

In this study, the investigators want to explore: will low-frequency transcutaneous electrical stimulation of the auricular branch of the vagus nerve contribute to weight loss in patients and improve their quality of life?

Study Type

Interventional

Enrollment (Actual)

131

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russia
      • Moscow, Russia
        • National Medical Research Center for Therapy and Preventive Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Adult patients with grade 1-2 nutritional obesity who are willing and able to give informed written consent to participate in the study, are on sinus rhythm and are not taking any antiarrhythmic drugs, including beta-blockers.

Exclusion Criteria:

  • Cardiac arrhythmias: bradyarrhythmias, Atrioventricular blockades of any degree;
  • Taking beta blockers;
  • The endocrine nature of obesity;
  • Expected technical difficulties when using the device on the part of the patient;
  • Pregnant or plan on becoming pregnant or breastfeeding during the study period;
  • Presence of an electrically, magnetically or mechanically activated implant, an intracerebral vascular clip, or any other electrically sensitive support system.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active TENS
Active will be performed with using a TENS device with an ear clip attached to the tragus of the right ear (which is innervated by auricular branch of the vagus nerve) at 25 Hz, 200ms at a current just below discomfort threshold.
Device: Active TENS
Active TENS stimulation will occur daily for 10 minutes, 3-4 times a day, 30 minutes before the main meals. The duration will be 6 months for each patient.
Sham Comparator: Sham TENS
Sham TENS will be performed to the ear lobe, which is devoid of vagal innervation.
Device: Sham TENS
Sham TENS stimulation will occur daily for 10 minutes, 3-4 times a day, 30 minutes before the main meals. The duration will be 6 months for each patient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of body fat
Time Frame: 6-month follow-up
It is calculated using the body composition analyzer "In Body 910" in dynamics (at the start and at the end of the trial).
6-month follow-up
Body Mass Index
Time Frame: 6-month follow-up
BMI will be determined by the equation (kg/m2) in dynamics (at the start and at the end of the trial).
6-month follow-up
Waist circumference
Time Frame: 6-month follow-up
Waist circumference will be measured on bare skin midway between the lowest rib and the superior border of the iliac crest using an inelastic measuring tape to the nearest 0.1 cm following the World Health Organization guideline. Measurement will be performed at the start and at the end of the trial.
6-month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Weight Loss
Time Frame: 6-month follow-up
The difference in weight in kilograms compared to the baseline value after 6 months observation within the trial.
6-month follow-up
Percentage of Total Weight Loss
Time Frame: 6-month follow-up
The ratio of the difference between the weight at the start of the trial and at the end of the trial in relation to the total body weight.
6-month follow-up
Eating behavior questionnaire
Time Frame: 6-month follow-up
The investigators will analyse changes in eating behavior using the Food Frequency Questionnaire (FFQ) and the 24-hour replay method.
6-month follow-up
Hip circumference
Time Frame: 6-month follow-up
Hip circumference will be taken on bare skin around the widest portion of the buttocks using an inelastic measuring tape to the nearest 0.1 cm and the tape should be placed parallel to the floor.
6-month follow-up
Waist circumference/Hip circumference
Time Frame: 6-month follow-up
The ratio of the two values (Waist Circumference/Hip circumference) will be performed at the start and at the end of the trial.
6-month follow-up
Lean Mass
Time Frame: 6-month follow-up
Lean mass will be simultaneously determined during the bioimpedance "In Body 910" scan for total body fat mass. Measurement will be performed at the start and at the end of the trial.
6-month follow-up
Health-related Quality of Life
Time Frame: 6-month follow-up
The validated short form survey measures health-related quality of life covering physical functioning, emotional and mental health, bodily pain, general health, vitality, and social functioning. A higher overall score indicates better quality of life.
6-month follow-up
Adherence
Time Frame: 6-month follow-up
Adherence will be verified by evaluating the completeness of the patient's diary.
6-month follow-up
Adverse Events
Time Frame: 6-month follow-up
Adverse events will be closely monitored regularly by research personnel, and by subjects' voluntary reports.
6-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Medical Research Center for Therapy and Preventive Medicine

Collaborators

Moscow State University of Medicine and Dentistry

Investigators

  • Principal Investigator: Oxana Drapkina, National Medical Research Center for Therapy and Preventive Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 4, 2022

Primary Completion (Estimated)

January 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

January 28, 2022

First Submitted That Met QC Criteria

January 28, 2022

First Posted (Actual)

February 9, 2022

Study Record Updates

Last Update Posted (Estimated)

September 3, 2025

Last Update Submitted That Met QC Criteria

August 26, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01-04/22

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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