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

NCT06332326 — Not applicable, Completed, 40 participants, Medipol University

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RegistryNCT06332326
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: triple, treatment
Enrollment40 (Actual)
SponsorMedipol University (Other)
ConditionsVestibular Diseases, Vestibular Vertigo, Vertigo
Interventionsnon-invasive vagus nerve stimulation, vestibular rehabilitation (Device, behavioral)
Datesstart 2021-10-15, primary completion 2024-04-15, completion 2024-06-15, first posted 2024-03-27, last updated 2025-03-25
Locations1 site in Turkey (Türkiye)

Related Papers Related Patents Related Grants Related Experts
All trials for Vestibular Diseases All trials for Vestibular Vertigo All trials of non-invasive vagus nerve stimulation All trials of vestibular rehabilitation

-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).

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+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).

+Arms and interventions

ArmTypeInterventionsDescription
VR+VAGUS GROUPExperimentalDevice: 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 GROUPActive comparatorBehavioral: vestibular rehabilitationVR GROUP (n=20) : PATİENTS UNDERGOİNG VESTİBULAR REHABİLİTATİON
  • 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.

+Outcome measures

Primary outcomes

  • Modified-CTSIB [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 [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 [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 [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 [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) [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 [5 minutes]: Dynamic visual acuity test; It measures the ability to see an object during rapid head movements.

Secondary outcomes

  • Dizziness Handicap Inventory Scale [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.
  • Tampa Kinesiophobia Scale [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.
  • Hospital Anxiety and Depression Scale (HAD) [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.

+Eligibility

Sex: All, ages: 18 Years to 50 Years

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

+Locations (1)

FacilityCityCountryStatus
Istanbul Medipol UniversityIstanbulTurkey (Türkiye)

+Investigators

  • tuğba türk kalkan, MD, Principal investigator, Medipol University