The Effect of Galvanic Stimulation on vHIT and VEMP Tests

November 3, 2023 updated by: Berna Özge MUTLU, Istanbul Medipol University Hospital

Introduction: Galvanic vestibular stimulation (GVS) is a well-established technique with a history spanning over a century, primarily used to manipulate the vestibular system. Recent interest has surged in its potential for understanding human vestibular function and aiding in functional recovery. GVS applies electrical currents to the mastoid region, modulating vestibular afferents, and induces specific effects based on the participant's posture and current polarity. While GVS's impact on the central nervous system and its potential to aid in functional recovery have been studied, its immediate effects on vestibular reflexes remain less explored.

Methods: In this study, thirty healthy adult participants underwent ocular and cervical vestibular evoked myogenic potential (VEMP) tests, as well as the velocity Head Impulse Test (vHIT) before and immediately after one hour of GVS application. Statistical analyses were performed to assess changes in VEMP and vHIT results.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34810
        • Istanbul Medipol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • No history of hearing loss and/or balance disorders
  • No physical (neck) problems
  • No history of psychological or neurological disorders
  • Not using alcohol and/or vestibular suppressant drugs regularly
  • Feeling balanced in daily life

Exclusion Criteria:

  • History of hearing loss and/or balance disorders
  • Physical (neck) problems
  • History of psychological or neurological disorders
  • Using alcohol and/or vestibular suppressant drugs regularly

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cervical Vestibuler Evoked Myogenic Potentials
Time Frame: 5 months
Vestibular evoked myogenic potentials (VEMPs) are muscle reflexes that occur in response to high-intensity acoustic stimuli delivered to the ear. These responses can be easily recorded using surface electrodes placed on the sternocleidomastoid muscle (SCM) or near the inferior oblique muscle .
5 months
Ocular Vestibuler Evoked Myogenic Potentials
Time Frame: 5 months
Vestibular evoked myogenic potentials (VEMPs) are muscle reflexes that occur in response to high-intensity acoustic stimuli delivered to the ear. Ocular VEMP (oVEMP) recorded from surface electrodes placed under the eyes.
5 months
Video Head Impulse Test
Time Frame: 5 months
The vestibulo-ocular reflex (VOR) is responsible for stabilizing images on the fovea during head movement. The velocity Head Impulse Test (vHIT) battery is a standard test for measuring head and eye movements, enabling the calculation of the gain of eye speed. The vHIT system typically employs light goggles to monitor eye position through cameras, along with a gyroscope to measure angular head movements, facilitating the computation of VOR gain.
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Medipol University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 25, 2019

Primary Completion (Actual)

June 10, 2020

Study Completion (Actual)

September 10, 2020

Study Registration Dates

First Submitted

October 27, 2023

First Submitted That Met QC Criteria

November 3, 2023

First Posted (Estimated)

November 9, 2023

Study Record Updates

Last Update Posted (Estimated)

November 9, 2023

Last Update Submitted That Met QC Criteria

November 3, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-10840098-604.01.01-41143

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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