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

Not Applicable

Completed

• Conditions: Vestibular Vertigo; Vertigo; Vestibular Diseases
• Interventions: Device: non-invasive vagus nerve stimulation; Behavioral: vestibular rehabilitation

• Registration Number: NCT06332326
• Lead Sponsor: Medipol University

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).

Study Timeline

• Study Start: 2021-10-15
• Study First Submitted: 2024-03-14
• Study First Submitted QC: 2024-03-25
• Study First Posted: 2024-03-27
• Primary Completion: 2024-04-15
• Study Completion: 2024-06-15
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VR+VAGUS GROUP	non-invasive vagus nerve stimulation	VR+VAGUS GROUP (n=20): PATIENTS USED NON-INVASIVE VAGUS NERVE STIMULATION IN ADDITION TO VESTIBULAR REHABILITATION
VR GROUP	vestibular rehabilitation	VR GROUP (n=20) : PATİENTS UNDERGOİNG VESTİBULAR REHABİLİTATİON
VR+VAGUS GROUP	vestibular rehabilitation	VR+VAGUS GROUP (n=20): PATIENTS USED NON-INVASIVE VAGUS NERVE STIMULATION IN ADDITION TO VESTIBULAR REHABILITATION

Primary Outcome Measures

Name	Time	Method
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.
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.
Dynamic visual acuity test	5 minutes	Dynamic visual acuity test; It measures the ability to see an object during rapid head movements.
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Istanbul Medipol University; 🇹🇷 Istanbul, Turkey