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Vestibular Stimulation to Trigger Adipose Loss (VeSTAL) Clinical Trial

NCT03640286 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 241

Last updated 2025-03-12

Study results available
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Summary

A randomized, double blind sham controlled clinical trial to evaluate the efficacy of vestibular nerve stimulation (VeNS), combined with a lifestyle modification program, compared to a sham control and a lifestyle modification program as a means of reducing excess body weight and body fat.

The purpose of this investigation device study is to collect data to support regulatory submissions, primarily in the United States of America (USA), but it may also be used to support submissions in other regions, including the European Union (EU).

Conditions

Interventions

DEVICE

VeSTAL

The aim of this study is to evaluate the efficacy of non-invasive electrical vestibular nerve stimulation in combination with a lifestyle modification program, as a method of reducing excess body weight and body fat, as compared to a sham device in combination with the same lifestyle modification program.

Sponsors & Collaborators

  • University of California, San Diego

    collaborator OTHER

  • University of Ulster

    collaborator OTHER

  • Exploristics

    collaborator UNKNOWN

  • Compliance Solutions Ltd.

    collaborator INDUSTRY

  • Neurovalens Ltd.

    lead INDUSTRY

Principal Investigators

  • Erik Viirre, MD PhD · UC San Diego

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-08-23
Primary Completion
2022-04-26
Completion
2022-04-26
FDA Device
Yes

Countries

  • United States
  • United Kingdom

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03640286 on ClinicalTrials.gov