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

November 10, 2023 updated by: Neurovalens Ltd.

Electrical Vestibular Nerve Stimulation (VeNS) Together With a Lifestyle Modification Program, Compared to a Sham Control With a Lifestyle Modification Program, as a Means of Reducing Excess Body Weight.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Madhya Pradesh
      • Ujjain, Madhya Pradesh, India, 456001
        • RD Gardi Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vestal active device
10 subjects to receive an active device plus a diet plan for 12 weeks.
Device: Vestal device
Battery powered non-invasive neurostimulation device
Behavioral: Lifestyle intervention
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lipid profile
Time Frame: 12 weeks
Blood sample to calculate ratio of Total Cholesterol: HDL and LDL
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Liver function tests
Time Frame: 12 weeks
Albumin test
12 weeks
Complete blood count
Time Frame: 12 weeks
Complete blood count
12 weeks
Glycated hemoglobin
Time Frame: 12 weeks
HbA1c as a percentage
12 weeks
Mean blood glucose
Time Frame: 12 weeks
Fasting glucose in mg/dL
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neurovalens Ltd.

Collaborators

RD Gardi Medical College

Investigators

  • Principal Investigator: Dr Sai Sailesh Kumar Goothy, RD Gardi Medical College, Ujjain

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2022

Primary Completion (Actual)

October 17, 2022

Study Completion (Actual)

October 17, 2022

Study Registration Dates

First Submitted

February 2, 2022

First Submitted That Met QC Criteria

March 2, 2022

First Posted (Actual)

March 11, 2022

Study Record Updates

Last Update Posted (Estimated)

November 13, 2023

Last Update Submitted That Met QC Criteria

November 10, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IVSWL001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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