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Clinical Trials/NCT06332326
NCT06332326
Completed
Not Applicable

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

Medipol University1 site in 1 country40 target enrollmentOctober 15, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Vestibular Diseases
Sponsor
Medipol University
Enrollment
40
Locations
1
Primary Endpoint
Unterberger test
Status
Completed
Last Updated
last year

Overview

Brief 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).

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).

Registry
clinicaltrials.gov
Start Date
October 15, 2021
End Date
June 15, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Medipol University
Responsible Party
Principal Investigator
Principal Investigator

Tugba Turk Kalkan

principal investigator

Medipol University

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

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.

Dynamic visual acuity test

Time Frame: 5 minutes

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

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.

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.

Secondary Outcomes

  • Tampa Kinesiophobia Scale(5 minutes)
  • Hospital Anxiety and Depression Scale (HAD)(5 minutes)
  • Dizziness Handicap Inventory Scale(5 minutes)

Study Sites (1)

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