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

Obesity 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05275790
• Other study ID #: IVSWL001
• Status: Completed
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: October 17, 2022

Study information

• Verified date: November 2023
• Source: Neurovalens Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 17, 2022
• Est. primary completion date: October 17, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

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.

Locations

Country	Name	City	State
India	RD Gardi Medical College	Ujjain	Madhya Pradesh

Sponsors (2)

Lead Sponsor	Collaborator
Neurovalens Ltd.	RD Gardi Medical College

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lipid profile	Blood sample to calculate ratio of Total Cholesterol: HDL and LDL	12 weeks
Secondary	Liver function tests	Albumin test	12 weeks
Secondary	Complete blood count	Complete blood count	12 weeks
Secondary	Glycated hemoglobin	HbA1c as a percentage	12 weeks
Secondary	Mean blood glucose	Fasting glucose in mg/dL	12 weeks