NCT06123949

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 25, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2020

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

October 27, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 9, 2023

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

10 months

First QC Date

October 27, 2023

Last Update Submit

November 8, 2023

Conditions

Keywords

galvanic vestibular stimulationVEMPvHIT

Outcome Measures

Primary Outcomes (3)

  • Cervical Vestibuler Evoked Myogenic Potentials

    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

    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

    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

Interventions

Galvanic Vestibular Stimulation (GVS) is a non-invasive technique that uses low-level electrical currents to stimulate the vestibular system, affecting balance, posture, and eye movements. It has applications in research, clinical assessment, and rehabilitation of vestibular and balance-related issues, as well as potential applications in cognitive and motor function enhancement.

Eligibility Criteria

Age18 Years - 22 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University

Istanbul, 34810, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Vestibular Diseases

Condition Hierarchy (Ancestors)

Labyrinth DiseasesEar DiseasesOtorhinolaryngologic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Inverstigator

Study Record Dates

First Submitted

October 27, 2023

First Posted

November 9, 2023

Study Start

August 25, 2019

Primary Completion

June 10, 2020

Study Completion

September 10, 2020

Last Updated

November 13, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations