Vestibular DiseasesNCT06332326
Investigation of the Efficacy of Non-Invasive Vagus Nerve Stimulation and Physiotherapy in Unilateral Vestibular Hypofunction Patients
A study testing non-invasive vagus nerve stimulation and vestibular rehabilitation in people with Vestibular Diseases and Vestibular Vertigo, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study: To investigate the effectiveness of non-invasive vagus nerve stimulation and vestibular rehabilitation applications in patients diagnosed with Unilateral Vestibular Hypofunction (UVH). Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Vestibular Diseases, Vestibular Vertigo, Vertigo
- What is being tested?
- non-invasive vagus nerve stimulation and vestibular rehabilitation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2021to 15 Jun 2024
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- He learned about unilateral peripheral vestibular hypofunction with videonystagmography
- Being able to communicate well
Who cannot join
- Having cognitive impairment
- Presence of central neurological disease
- Lack of cooperation
- Previous ear surgery
- Accompanied by Benign Proxysmal Positional Vertigo
- Having acute Meniere's disease
Show all 9Show fewer
- Finding pathology in temporal bone MRI
- Having a lower extremity disorder that prevents walking
- Evidence of central pathology in videonystagmography results
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study: To investigate the effectiveness of non-invasive vagus nerve stimulation and vestibular rehabilitation applications in patients diagnosed with Unilateral Vestibular Hypofunction (UVH).
Read the detailed description
It was planned to include 40 patients diagnosed with UHV in the study. Patients were randomized into 2 separate groups (20 people in the vestibular rehabilitation group, 20 people in the vagus nerve stimulation group in addition to vestibular rehabilitation).
- Conditions
- Vestibular Diseases, Vestibular Vertigo, Vertigo
- Being tested
- non-invasive vagus nerve stimulation, vestibular rehabilitation
- Keywords
- unilateral vestibular hypofunction, Non-Invasive Vagus Nerve Stimulation, balance, vestibular rehabilitation
- Medical subject headings
- Vestibular Diseases, Vertigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-invasive vagus nerve stimulationDevice
non-invasive vagus nerve stimulation: patients will receive non-invasive vagus nerve stimulation.
vestibular rehabilitationBehavioural
vestibular rehabilitation: Patients will be given specially structured vestibular rehabilitation exercises.
| Study group | Role | What they receive |
|---|---|---|
| VR+VAGUS GROUP | Experimental | VR+VAGUS GROUP (n=20): PATIENTS USED NON-INVASIVE VAGUS NERVE STIMULATION IN ADDITION TO VESTIBULAR REHABILITATION Receives: Device: non-invasive vagus nerve stimulation; Behavioral: vestibular rehabilitation |
| VR GROUP | Active comparator | VR GROUP (n=20) : PATİENTS UNDERGOİNG VESTİBULAR REHABİLİTATİON Receives: Behavioral: vestibular rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified-CTSIB
Modified-CTSIB; It is generally used as a semi-quantitative test measurement and clinical practice in which points are scored based on the ability to perform various standing static positions It is a test. It covers different situations where the patient must stand under different conditions: foam surface versus hard floor, tested with eyes open and closed in six different test groups.
Measured: 30 minutes
Semitandem test
semitandem stance positions; The conditions (sec) of remaining in balance with eyes open and closed on hard and soft surfaces will be measured.
Measured: 10 minutes
tandem test
tandem semitandem stance positions; The conditions (sec) of remaining in balance with eyes open and closed on hard and soft surfaces will be measured.
Measured: 10 minutes
one-leg standing test
one-leg standing test; The conditions (sec) of remaining in balance with eyes open and closed on hard and soft surfaces will be measured.
Measured: 10 minutes
Unterberger test
Unterberger test: The patient first takes 10 steps quickly with his eyes open, then With his eyes closed, he takes 50 steps quickly in place. If there is a lesion, apply it to the side of the lesion.
correct deviation occurs.
Measured: 5 minutes
VAS Visual Analogue Scale (dizziness severity)
Visual Analogue Scale will be applied to evaluate dizziness severity and patient satisfaction. With this scale, scoring from 0 to 10 is requested. While 0 indicates the lowest dizziness severity and lowest patient satisfaction, 10 indicates the highest dizziness severity and highest patient satisfaction.
Measured: 5 minutes
Dynamic visual acuity test
Dynamic visual acuity test; It measures the ability to see an object during rapid head movements.
Measured: 5 minutes
Secondary outcomes (3)
Dizziness Handicap Inventory Scale
It was developed to measure disability in patients complaining of dizziness and imbalance and is used in treatment follow-up. It is a survey consisting of 25 questions about the patient's physical (7 questions), functional (9 questions) and emotional (9 questions) status, and which patients can apply themselves in line with their complaints. Patients rate the questions as 0 (no), 2 (sometimes) and 4 (yes) based on their complaints. high scores describe severe dizziness.
Measured: 5 minutes
Tampa Kinesiophobia Scale
The Tampa Kinesiophobia Scale will be used to evaluate kinesiophobia. It is a 17-question scale developed to measure fear of injury. The scale includes injury/re-injury and fear-avoidance parameters in work-related activities. High scores describe severe kinesiophobia.
Measured: 5 minutes
Hospital Anxiety and Depression Scale (HAD)
The Tampa Kinesiophobia Scale will be used to evaluate kinesiophobia. It is a 17-question scale developed to measure fear of injury. The scale includes injury/re-injury and fear-avoidance parameters in work-related activities. High scores describe higher levels of depression and anxiety.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start15 Oct 2021
- Primary completion15 Apr 2024
- Study completion15 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular DiseasesStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 40 patients diagnosed with UHV were included. Patients were randomized into 2 separate groups (20 people in the vestibular rehabilitation group, 20 people in the vagus nerve stimulation group in addition to vestibular rehabilitation).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tugba Turk Kalkan, Medipol University
- Investigators
- tuğba türk kalkan, MD, Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06332326
- Sponsor's protocol ID
- E-10840098-772.02-4966
- Status last verified
- Mar 2025
- First submitted
- 14 Mar 2024
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Efficacy of Non-Invasive Vagus Nerve Stimulation and Physiotherapy in Unilateral Vestibular Hypofunction Patients
- ClinicalTrials.gov ID
- NCT06332326
- Acronym / sponsor ID
- E-10840098-772.02-4966
- Conditions
- Vestibular Diseases, Vestibular Vertigo, Vertigo
- Keywords
- unilateral vestibular hypofunction, Non-Invasive Vagus Nerve Stimulation, balance, vestibular rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 15 Jun 2024 (actual)
- First posted
- 27 Mar 2024 (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.
The purpose of this study: To investigate the effectiveness of non-invasive vagus nerve stimulation and vestibular rehabilitation applications in patients diagnosed with Unilateral Vestibular Hypofunction (UVH).
Detailed description
It was planned to include 40 patients diagnosed with UHV in the study. Patients were randomized into 2 separate groups (20 people in the vestibular rehabilitation group, 20 people in the vagus nerve stimulation group in addition to vestibular rehabilitation).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 40 patients diagnosed with UHV were included. Patients were randomized into 2 separate groups (20 people in the vestibular rehabilitation group, 20 people in the vagus nerve stimulation group in addition to vestibular rehabilitation).
| Arm | Type | Receives |
|---|---|---|
| VR+VAGUS GROUP | Experimental | Device: non-invasive vagus nerve stimulation, Behavioral: vestibular rehabilitationVR+VAGUS GROUP (n=20): PATIENTS USED NON-INVASIVE VAGUS NERVE STIMULATION IN ADDITION TO VESTIBULAR REHABILITATION |
| VR GROUP | Active comparator | Behavioral: vestibular rehabilitationVR GROUP (n=20) : PATİENTS UNDERGOİNG VESTİBULAR REHABİLİTATİON |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- He learned about unilateral peripheral vestibular hypofunction with videonystagmography
- Being able to communicate well
Key exclusion criteria (9 listed)
- Having cognitive impairment
- Presence of central neurological disease
- Lack of cooperation
- Previous ear surgery
- Accompanied by Benign Proxysmal Positional Vertigo
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 |
|---|---|---|
| non-invasive vagus nerve stimulationnon-invasive vagus nerve stimulation: patients will receive non-invasive vagus nerve stimulation. | Device | VR+VAGUS GROUP |
| vestibular rehabilitationvestibular rehabilitation: Patients will be given specially structured vestibular rehabilitation exercises. | Behavioural | VR GROUP, VR+VAGUS GROUP |
Primary outcome
Modified-CTSIB
Time frame: 30 minutes
Modified-CTSIB; It is generally used as a semi-quantitative test measurement and clinical practice in which points are scored based on the ability to perform various standing static positions It is a test. It covers different situations where the patient must stand under different conditions: foam surface versus hard floor, tested with eyes open and closed in six different test groups.
Semitandem test
Time frame: 10 minutes
semitandem stance positions; The conditions (sec) of remaining in balance with eyes open and closed on hard and soft surfaces will be measured.
tandem test
Time frame: 10 minutes
tandem semitandem stance positions; The conditions (sec) of remaining in balance with eyes open and closed on hard and soft surfaces will be measured.
one-leg standing test
Time frame: 10 minutes
one-leg standing test; The conditions (sec) of remaining in balance with eyes open and closed on hard and soft surfaces will be measured.
Unterberger test
Time frame: 5 minutes
Unterberger test: The patient first takes 10 steps quickly with his eyes open, then With his eyes closed, he takes 50 steps quickly in place. If there is a lesion, apply it to the side of the lesion. correct deviation occurs.
VAS Visual Analogue Scale (dizziness severity)
Time frame: 5 minutes
Visual Analogue Scale will be applied to evaluate dizziness severity and patient satisfaction. With this scale, scoring from 0 to 10 is requested. While 0 indicates the lowest dizziness severity and lowest patient satisfaction, 10 indicates the highest dizziness severity and highest patient satisfaction.
Dynamic visual acuity test
Time frame: 5 minutes
Dynamic visual acuity test; It measures the ability to see an object during rapid head movements.
3 secondary outcomes
Dizziness Handicap Inventory Scale
Time frame: 5 minutes
Tampa Kinesiophobia Scale
Time frame: 5 minutes
Hospital Anxiety and Depression Scale (HAD)
Time frame: 5 minutes
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 25 Mar 2025.
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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.
tuğba türk kalkan, MD principal investigator
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non-invasive vagus nerve stimulation and vestibular rehabilitation in people with Vestibular Diseases and Vestibular Vertigo, run by Medipol University 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 2 inclusion and 9 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 25 Mar 2025. 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?
Modified-CTSIB (time frame: 30 minutes). The study lists 7 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 25 Mar 2025.