Vestibular System DisorderNCT06123949
The Effect of Galvanic Stimulation on vHIT and VEMP Tests
A study testing Galvanic Vestibular Stimulation in people with Vestibular System Disorder, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 22 yearsHealthy volunteers can take part
- Conditions the study is for
- Vestibular System Disorder
- What is being tested?
- Galvanic Vestibular Stimulation
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Aug 2019to 10 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 22 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Vestibular System Disorder
- Being tested
- Galvanic Vestibular Stimulation
- Keywords
- galvanic vestibular stimulation, VEMP, vHIT
- Medical subject headings
- Vestibular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Galvanic Vestibular StimulationDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: 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.
Measured: 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.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start25 Aug 2019
- Primary completion10 Jun 2020
- Study completion10 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular System DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berna Özge MUTLU, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06123949
- Sponsor's protocol ID
- E-10840098-604.01.01-41143
- Status last verified
- Nov 2023
- First submitted
- 27 Oct 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Galvanic Stimulation on vHIT and VEMP Tests
- ClinicalTrials.gov ID
- NCT06123949
- Acronym / sponsor ID
- E-10840098-604.01.01-41143
- Conditions
- Vestibular System Disorder
- Keywords
- galvanic vestibular stimulation, VEMP, vHIT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 25 Aug 2019 (actual)
- Primary completion
- 10 Jun 2020 (actual)
- Study completion
- 10 Sep 2020 (actual)
- First posted
- 9 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 22 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Galvanic Vestibular StimulationGalvanic 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. | Device | – |
Primary outcome
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 .
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Galvanic Vestibular Stimulation in people with Vestibular System Disorder, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cervical Vestibuler Evoked Myogenic Potentials (time frame: 5 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.