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

NCT ID: NCT05275790

Last Updated: 2023-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2022-10-17

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vestal active device

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

Group Type EXPERIMENTAL

Vestal device

Intervention Type DEVICE

Battery powered non-invasive neurostimulation device

Lifestyle intervention

Intervention Type BEHAVIORAL

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.

Interventions

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Vestal device

Battery powered non-invasive neurostimulation device

Intervention Type DEVICE

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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RD Gardi Medical College

UNKNOWN

Sponsor Role collaborator

Neurovalens Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dr Sai Sailesh Kumar Goothy

Role: PRINCIPAL_INVESTIGATOR

RD Gardi Medical College, Ujjain

Locations

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RD Gardi Medical College

Ujjain, Madhya Pradesh, India

Site Status

Countries

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India

Other Identifiers

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IVSWL001

Identifier Type: -

Identifier Source: org_study_id

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