Auricular Vagus Stimulation in Obesity

NCT05230628 | Active Not Recruiting

• 1 other identifier: 01-04/22
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vagus Nerve Stimulation; Obesity

Keywords

auricular stimulation; auricular vagus nerve stimulation; blinding (masking); transcutaneous vagus nerve stimulation (TENS); vagus nerve stimulation (VNS); obesity abdominal; nutrition disorders; overweight; body weight; active TENS; sham TENS; heart rate; total fat; body mass index; waist circumference; hip circumference; Heart rate variability; quality of life

Outcome Measures

Primary Outcomes (3)

• Percentage of body fat

  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

  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

  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 Outcomes (9)

• Total Weight Loss

  6-month follow-up

• Percentage of Total Weight Loss

  6-month follow-up

• Eating behavior questionnaire

  6-month follow-up

• Hip circumference

  6-month follow-up

• Waist circumference/Hip circumference

  6-month follow-up

Study Arms (2)

Active TENS

EXPERIMENTAL

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

Sham TENS

SHAM COMPARATOR

Sham TENS will be performed to the ear lobe, which is devoid of vagal innervation.

Device: Sham TENS

Interventions

Active TENS DEVICE

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.

Active TENS

Sham TENS DEVICE

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.

Sham TENS

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Medical Research Center for Therapy and Preventive Medicine: lead
• Moscow State University of Medicine and Dentistry: collaborator

Study Sites (1)

National Medical Research Center for Therapy and Preventive Medicine

Moscow, Russia

Location

Related Publications (5)

• Kim WS, Hong S, Gamero M, Jeevakumar V, Smithhart CM, Price TJ, Palmiter RD, Campos C, Park SI. Organ-specific, multimodal, wireless optoelectronics for high-throughput phenotyping of peripheral neural pathways. Nat Commun. 2021 Jan 8;12(1):157. doi: 10.1038/s41467-020-20421-8.

  PMID: 33420038 BACKGROUND

• Verma N, Mudge JD, Kasole M, Chen RC, Blanz SL, Trevathan JK, Lovett EG, Williams JC, Ludwig KA. Auricular Vagus Neuromodulation-A Systematic Review on Quality of Evidence and Clinical Effects. Front Neurosci. 2021 Apr 30;15:664740. doi: 10.3389/fnins.2021.664740. eCollection 2021.

  PMID: 33994937 BACKGROUND

• Stavrakis S, Stoner JA, Humphrey MB, Morris L, Filiberti A, Reynolds JC, Elkholey K, Javed I, Twidale N, Riha P, Varahan S, Scherlag BJ, Jackman WM, Dasari TW, Po SS. TREAT AF (Transcutaneous Electrical Vagus Nerve Stimulation to Suppress Atrial Fibrillation): A Randomized Clinical Trial. JACC Clin Electrophysiol. 2020 Mar;6(3):282-291. doi: 10.1016/j.jacep.2019.11.008. Epub 2020 Jan 29.

  PMID: 32192678 BACKGROUND

• Wolf V, Kuhnel A, Teckentrup V, Koenig J, Kroemer NB. Does transcutaneous auricular vagus nerve stimulation affect vagally mediated heart rate variability? A living and interactive Bayesian meta-analysis. Psychophysiology. 2021 Nov;58(11):e13933. doi: 10.1111/psyp.13933. Epub 2021 Sep 2.

  PMID: 34473846 BACKGROUND

• Yap JYY, Keatch C, Lambert E, Woods W, Stoddart PR, Kameneva T. Critical Review of Transcutaneous Vagus Nerve Stimulation: Challenges for Translation to Clinical Practice. Front Neurosci. 2020 Apr 28;14:284. doi: 10.3389/fnins.2020.00284. eCollection 2020.

  PMID: 32410932 BACKGROUND

MeSH Terms

Conditions

Obesity; Obesity, Abdominal; Nutrition Disorders; Overweight; Body Weight

Condition Hierarchy (Ancestors)

Overnutrition; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Oxana Drapkina

  National Medical Research Center for Therapy and Preventive Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Model: 1:1 randomization of active stimulation vs. no stimulation for 6 months post randomization.

Study Record Dates

• First Submitted: January 28, 2022
• First Posted: February 9, 2022
• Study Start: April 4, 2022
• Primary Completion: January 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 3, 2025

Record last verified: 2025-08

Locations

RU (1)