Status:
ACTIVE_NOT_RECRUITING
Auricular Vagus Stimulation in Obesity
Lead Sponsor:
National Medical Research Center for Therapy and Preventive Medicine
Collaborating Sponsors:
Moscow State University of Medicine and Dentistry
Conditions:
Vagus Nerve Stimulation
Obesity
Eligibility:
All Genders
18-75 years
Phase:
NA
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 possibiliti...
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 projecti...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2026
Estimated Enrollment :
131 Patients enrolled
Trial Details
Trial ID
NCT05230628
Start Date
April 4 2022
End Date
December 31 2026
Last Update
September 3 2025
Active Locations (1)
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1
National Medical Research Center for Therapy and Preventive Medicine
Moscow, Russia