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Auricular Vagus Stimulation in Obesity

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ClinicalTrials.gov Identifier: NCT05230628
Recruitment Status : Active, not recruiting
First Posted : February 9, 2022
Last Update Posted : March 26, 2024
Sponsor:
Collaborator:
Moscow State University of Medicine and Dentistry
Information provided by (Responsible Party):
National Medical Research Center for Therapy and Preventive Medicine

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.

Condition or disease Intervention/treatment Phase
Vagus Nerve Stimulation Obesity Device: Active TENS Device: Sham TENS Not Applicable

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?

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 131 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Model: 1:1 randomization of active stimulation vs. no stimulation for 6 months post randomization.
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : April 4, 2022
Actual Primary Completion Date : January 31, 2024
Estimated Study Completion Date : December 31, 2024

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.




Primary Outcome Measures :
  1. 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).

  2. 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).

  3. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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. 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.

  7. 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.

  8. Adherence [ Time Frame: 6-month follow-up ]
    Adherence will be verified by evaluating the completeness of the patient's diary.

  9. Adverse Events [ Time Frame: 6-month follow-up ]
    Adverse events will be closely monitored regularly by research personnel, and by subjects' voluntary reports.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05230628


Locations
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Russian Federation
National Medical Research Center for Therapy and Preventive Medicine
Moscow, Russian Federation
Sponsors and Collaborators
National Medical Research Center for Therapy and Preventive Medicine
Moscow State University of Medicine and Dentistry
Investigators
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Principal Investigator: Oxana Drapkina National Medical Research Center for Therapy and Preventive Medicine
Publications:
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Responsible Party: National Medical Research Center for Therapy and Preventive Medicine
ClinicalTrials.gov Identifier: NCT05230628    
Other Study ID Numbers: 01-04/22
First Posted: February 9, 2022    Key Record Dates
Last Update Posted: March 26, 2024
Last Verified: March 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Medical Research Center for Therapy and Preventive Medicine:
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
Additional relevant MeSH terms:
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Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight