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).

Study Overview

• Status: Recruiting
• Conditions: Vertigo; Vestibular Diseases; Vestibular Vertigo
• Intervention / Treatment: Device: non-invasive vagus nerve stimulation; Behavioral: vestibular rehabilitation

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: tuğba türk kalkan, MD; Phone Number: +905334956459; Email: tugbatrkk@gmail.com

Study Locations

• Turkey
  • Istanbul, Turkey
    • Recruiting
    • Istanbul Medipol University
    • Contact: tuğba türk kalkan, MD; Phone Number: +905334956459; Email: tugbatrkk@gmail.com
    • Principal Investigator: tugba türk kalkan, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VR+VAGUS GROUP; VR+VAGUS GROUP (n=20): PATIENTS USED NON-INVASIVE VAGUS NERVE STIMULATION IN ADDITION TO VESTIBULAR REHABILITATION	Device: non-invasive vagus nerve stimulation; non-invasive vagus nerve stimulation: patients will receive non-invasive vagus nerve stimulation.; Behavioral: vestibular rehabilitation; vestibular rehabilitation: Patients will be given specially structured vestibular rehabilitation exercises.
Active Comparator: VR GROUP; VR GROUP (n=20) : PATİENTS UNDERGOİNG VESTİBULAR REHABİLİTATİON	Behavioral: vestibular rehabilitation; vestibular rehabilitation: Patients will be given specially structured vestibular rehabilitation exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	5 minutes
Dynamic visual acuity test	Dynamic visual acuity test; It measures the ability to see an object during rapid head movements.	5 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	5 minutes

Collaborators and Investigators

• Sponsor: Medipol University
• Investigators: Principal Investigator: tuğba türk kalkan, MD, Medipol University

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2022
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: March 14, 2024
• First Submitted That Met QC Criteria: March 25, 2024
• First Posted (Actual): March 27, 2024

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 25, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: balance; vestibular rehabilitation; unilateral vestibular hypofunction; Non-Invasive Vagus Nerve Stimulation
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Labyrinth Diseases; Ear Diseases; Sensation Disorders; Vertigo; Dizziness; Vestibular Diseases
• Other Study ID Numbers: E-10840098-772.02-4966

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No