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

Primary Purpose

Obesity

Status
Recruiting
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Vestal device
Lifestyle intervention
Sponsored by
Neurovalens Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • RD Gardi Medical CollegeRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vestal active device

Arm Description

10 subjects to receive an active device plus a diet plan for 12 weeks.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Liver function tests
Albumin test
Complete blood count
Complete blood count
Glycated hemoglobin
HbA1c as a percentage
Mean blood glucose
Fasting glucose in mg/dL

Full Information

First Posted
February 2, 2022
Last Updated
August 8, 2022
Sponsor
Neurovalens Ltd.
Collaborators
RD Gardi Medical College
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1. Study Identification

Unique Protocol Identification Number
NCT05275790
Brief Title
Efficacy of Electrical Vestibular Nerve Stimulation (VeNS) in the Management of Obesity: A Randomized Clinical Trial
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
October 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neurovalens Ltd.
Collaborators
RD Gardi Medical College

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Bilateral electrical vestibular nerve stimulation will be administered using a battery-powered vestibular nerve stimulator (ML 1000). Participants will act as their own self-control.
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vestal active device
Arm Type
Experimental
Arm Description
10 subjects to receive an active device plus a diet plan for 12 weeks.
Intervention Type
Device
Intervention Name(s)
Vestal device
Intervention Description
Battery powered non-invasive neurostimulation device
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Lipid profile
Description
Blood sample to calculate ratio of Total Cholesterol: HDL and LDL
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Liver function tests
Description
Albumin test
Time Frame
12 weeks
Title
Complete blood count
Description
Complete blood count
Time Frame
12 weeks
Title
Glycated hemoglobin
Description
HbA1c as a percentage
Time Frame
12 weeks
Title
Mean blood glucose
Description
Fasting glucose in mg/dL
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr Sai Sailesh Kumar Goothy
Phone
9061076459
Ext
+91
Email
trials@neurovalens.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Sai Sailesh Kumar Goothy
Organizational Affiliation
RD Gardi Medical College, Ujjain
Official's Role
Principal Investigator
Facility Information:
Facility Name
RD Gardi Medical College
City
Ujjain
State/Province
Madhya Pradesh
ZIP/Postal Code
456001
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sai Sailesh Kumar Goothy

12. IPD Sharing Statement

Learn more about this trial

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

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