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

Vertigo Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06332326
• Other study ID #: E-10840098-772.02-4966
• Status: Recruiting
• Phase: N/A
• Start date: October 23, 2022
• Est. completion date: May 2024

Study information

• Verified date: March 2024
• Source: Medipol University
• Contact: tugba türk kalkan, MD
• Phone: +905334956459
• Email: tugbatrkk[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Dizziness
• Vertigo
• Vestibular Diseases
• Vestibular Vertigo

Intervention

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.

Locations

Country	Name	City	State
Turkey	Istanbul Medipol University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Medipol University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Dynamic visual acuity test	Dynamic visual acuity test; It measures the ability to see an object during rapid head movements.	5 minutes
Secondary	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
Secondary	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
Secondary	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