Clinical trial

Auricular Vagus Stimulation in Obesity

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT05230628

Active, not recruitingNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 75 Years

SexAll

Healthy volunteersNot accepted

ConditionVagus Nerve Stimulation, Obesity

Full registry 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.

Treatments and study arms

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.

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.

Primary outcomes

Percentage of body fat6-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 Index6-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 circumference6-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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

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

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