Vagus Nerve StimulationNCT05230628
Auricular Vagus Stimulation in Obesity
A study testing Active TENS in people with Vagus Nerve Stimulation and Obesity, run by National Medical Research Center for Therapy and Preventive Medicine at 1 site in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Vagus Nerve Stimulation, Obesity
- What is being tested?
- Active TENS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 131 participants
- Where
- 1 siteRussia
- Study dates
- 4 Apr 2022to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Russia1 site
National Medical Research Center for Therapy and Preventive Medicine
Moscow
About this study
Official title: 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.
Read the 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?
- Conditions
- Vagus Nerve Stimulation, Obesity
- Being tested
- Active TENS, Sham TENS
- 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
- Medical subject headings
- Obesity, Obesity, Abdominal, Nutrition Disorders, Overweight, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active TENSDevice
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 TENSDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Active TENS |
| Sham TENS | Sham comparator | Sham TENS will be performed to the ear lobe, which is devoid of vagal innervation. Receives: Device: Sham TENS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Measured: 6-month follow-up
Secondary outcomes (9)
Total Weight Loss
The difference in weight in kilograms compared to the baseline value after 6 months observation within the trial.
Measured: 6-month follow-up
Percentage of Total Weight Loss
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.
Measured: 6-month follow-up
Eating behavior questionnaire
The investigators will analyse changes in eating behavior using the Food Frequency Questionnaire (FFQ) and the 24-hour replay method.
Measured: 6-month follow-up
Hip circumference
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.
Measured: 6-month follow-up
Waist circumference/Hip circumference
The ratio of the two values (Waist Circumference/Hip circumference) will be performed at the start and at the end of the trial.
Measured: 6-month follow-up
Lean Mass
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.
Measured: 6-month follow-up
Health-related Quality of Life
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.
Measured: 6-month follow-up
Adherence
Adherence will be verified by evaluating the completeness of the patient's diary.
Measured: 6-month follow-up
Adverse Events
Adverse events will be closely monitored regularly by research personnel, and by subjects' voluntary reports.
Measured: 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start4 Apr 2022
- Primary completion31 Jan 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Vagus Nerve StimulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Model: 1:1 randomization of active stimulation vs. no stimulation for 6 months post randomization.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Medical Research Center for Therapy and Preventive Medicine
- Sponsor type
- Other government
- Collaborators
- Moscow State University of Medicine and Dentistry
- Responsible party
- Sponsor
- Investigators
- Oxana Drapkina, Principal investigator, National Medical Research Center for Therapy and Preventive Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05230628
- Sponsor's protocol ID
- 01-04/22
- Status last verified
- Aug 2025
- First submitted
- 28 Jan 2022
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33420038Verma 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.
PubMed 33994937Stavrakis 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.
PubMed 32192678Wolf 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.
PubMed 34473846Yap 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.
PubMed 32410932
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05230628
- Acronym / sponsor ID
- 01-04/22
- 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
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 131 participants (actual)
- Lead sponsor
- National Medical Research Center for Therapy and Preventive MedicineOther government
- Collaborators
- Moscow State University of Medicine and Dentistry
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Model: 1:1 randomization of active stimulation vs. no stimulation for 6 months post randomization.
| Arm | Type | Receives |
|---|---|---|
| Active TENS | Experimental | Device: Active TENSActive 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. |
| Sham TENS | Sham comparator | Device: Sham TENSSham TENS will be performed to the ear lobe, which is devoid of vagal innervation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active TENSActive 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. | Device | Active TENS |
| Sham TENSSham 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. | Device | Sham TENS |
Primary outcome
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).
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).
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.
9 secondary outcomes
Total Weight Loss
Time frame: 6-month follow-up
Percentage of Total Weight Loss
Time frame: 6-month follow-up
Eating behavior questionnaire
Time frame: 6-month follow-up
Hip circumference
Time frame: 6-month follow-up
Waist circumference/Hip circumference
Time frame: 6-month follow-up
Lean Mass
Time frame: 6-month follow-up
Health-related Quality of Life
Time frame: 6-month follow-up
Adherence
Time frame: 6-month follow-up
Adverse Events
Time frame: 6-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Background: PubMed 33420038Kim 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.
- Background: PubMed 33994937Verma 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.
- Background: PubMed 32192678Stavrakis 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.
- Background: PubMed 34473846Wolf 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.
- Background: PubMed 32410932Yap 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oxana Drapkina principal investigator
National Medical Research Center for Therapy and Preventive Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active TENS in people with Vagus Nerve Stimulation and Obesity, run by National Medical Research Center for Therapy and Preventive Medicine at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of body fat (time frame: 6-month follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05230628, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.