Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06332326
Other study ID # E-10840098-772.02-4966
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05649891 - Checklists Resuscitation Emergency Department N/A
Recruiting NCT05533840 - Establishment and Application of a New Imaging System for Otology Based on Ultra-high Resolution CT
Completed NCT02533739 - Vestibular Disorder and Visuo-spatial Functions N/A
Completed NCT01153789 - Study of Oculomotor Dysfunction Leading to Children Vertigo N/A
Completed NCT00765635 - Chlorobutanol, Potassium Carbonate, and Irrigation in Cerumen Removal Phase 4
Not yet recruiting NCT04929444 - Training to Improve Vertigo Management in Primary Care N/A
Completed NCT04458376 - Internet-based Self-help Program for Vestibular Rehabilitation in Chronic Dizziness N/A
Not yet recruiting NCT04055766 - A Diagnostic Test on DeepDoc-an AI-based Decision Support System
Completed NCT02938221 - Telemedical Examination of a Three-Component Oculomotor Testing Battery N/A
Active, not recruiting NCT02655575 - Assessment and Treatment of Patients With Long-term Dizziness in Primary Care N/A
Completed NCT02457455 - Urgent Medical and Surgical Conditions During Flights N/A
Enrolling by invitation NCT01426932 - The Head Impulse Test in the Screening of Vestibular Function N/A
Completed NCT00000359 - Treatments for Benign Paroxysmal Positional Vertigo (BPPV) Phase 2
Not yet recruiting NCT06010550 - Validating a Clinical Decision Support Tool for Stratifying Stroke Risk for Dizziness/Vertigo
Not yet recruiting NCT06017466 - Translation and Implementation of the Dutch VVAS Score in Clinical Practice N/A
Completed NCT04598113 - Effect of Cervical Traction on Balance in Cervical Radiculopathy Patients N/A
Completed NCT05157399 - Quantification of the Effect of the OtoBand on Objective Measures of Vertigo and Dizziness N/A
Completed NCT05897853 - Impact of Vertigoheel® on Patients Suffering From Bilateral Vestibulopathy and Functional Dizziness
Completed NCT05221892 - Evaluation of Aminobutyric Acid, Glutamic Acid, Calcium, Thiamine, Pyridoxine and Cyanocobalamin as Therapy for Vertigo Phase 4
Completed NCT02253524 - Comparison of Efficacy Dimenhydrinate and Metoclopramide in the Treatment of Nausea Due to Vertigo Phase 4