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Completed

NCT Number: NCT06332326

Investigation of the Efficacy of Non-Invasive Vagus Nerve Stimulation and Physiotherapy in Unilateral Vestibular Hypofunction Patients

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).

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Key information

Conditions

Vestibular Diseases Ear Diseases Labyrinth Diseases Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Vertigo Vestibular Vertigo

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Medipol University

Istanbul, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • He learned about unilateral peripheral vestibular hypofunction with videonystagmography
  • Being able to communicate well

Exclusion criteria

  • 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
  • Finding pathology in temporal bone MRI
  • Having a lower extremity disorder that prevents walking
  • Evidence of central pathology in videonystagmography results

Treatment and study plan

Non-Invasive Vagus Nerve Stimulation

Device

non-invasive vagus nerve stimulation: patients will receive non-invasive vagus nerve stimulation.

Vestibular rehabilitation

Behavioral

vestibular rehabilitation: Patients will be given specially structured vestibular rehabilitation exercises.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. Dynamic visual acuity test

    Time frame: 5 minutes

    Dynamic visual acuity test; It measures the ability to see an object during rapid head movements.

Secondary outcomes

  1. Dizziness Handicap Inventory Scale

    Time frame: 5 minutes

    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.

  2. Tampa Kinesiophobia Scale

    Time frame: 5 minutes

    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.

  3. Hospital Anxiety and Depression Scale (HAD)

    Time frame: 5 minutes

    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.

Sponsors and collaborators

Lead sponsor

Medipol University

Other

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Mar 27, 2024
Registry last updated
Mar 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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