Efficacy of Electrical Vestibular Nerve Stimulation (VeNS) in the Management of Obesity: A Randomized Clinical Trial

Neurovalens Ltd.10 enrolled

Overview

The aim of this study is to observe the efficacy of electrical vestibular nerve stimulation in the management of obesity. Allocation: Active device (participants act as their own self-control) Endpoint classification: Efficacy Study. The study provides further evidence for the efficacy of electrical vestibular nerve stimulation in the management of obesity.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Obesity

Interventions

Vestal deviceDEVICE

Battery powered non-invasive neurostimulation device

Lifestyle interventionBEHAVIORAL

All subjects will be prescribed a diet plan and instructed to follow it for the duration of the 12-week study. The diet plan will be designed by the P.I. who is a qualified, obesity management coach.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * BMI 30 to 40 kg/m2 * Aged above 18 years Exclusion Criteria: * Current use of any medications or therapy including use of oral contraceptives * Use of dietary supplements known to affect the BMI * Ear problems (assessed during physical examination) * Any severe complications * Unwilling participants

Locations (1)

RD Gardi Medical College

Ujjain, Madhya Pradesh, India

Outcomes

Primary Outcomes

Lipid profile

Blood sample to calculate ratio of Total Cholesterol: HDL and LDL

Time frame: 12 weeks

Secondary Outcomes

Liver function tests

Albumin test

Time frame: 12 weeks

Complete blood count

Time frame: 12 weeks

Glycated hemoglobin

HbA1c as a percentage

Time frame: 12 weeks

Mean blood glucose

Fasting glucose in mg/dL

Time frame: 12 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.