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
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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COMPLETED
NA
10 participants
INTERVENTIONAL
2022-04-01
2022-10-17
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Vestal active device
10 subjects to receive an active device plus a diet plan for 12 weeks.
Vestal device
Battery powered non-invasive neurostimulation 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.
Interventions
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Vestal device
Battery powered non-invasive neurostimulation 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.
Eligibility Criteria
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Inclusion Criteria
* Aged above 18 years
Exclusion Criteria
* Use of dietary supplements known to affect the BMI
* Ear problems (assessed during physical examination)
* Any severe complications
* Unwilling participants
18 Years
ALL
Yes
Sponsors
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RD Gardi Medical College
UNKNOWN
Neurovalens Ltd.
INDUSTRY
Responsible Party
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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
Countries
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Other Identifiers
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IVSWL001
Identifier Type: -
Identifier Source: org_study_id
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