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

NCT06332326 | Completed DMC

• 1 other identifier: E-10840098-772.02-4966
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Vestibular Diseases; Vestibular Vertigo; Vertigo

Keywords

unilateral vestibular hypofunction; Non-Invasive Vagus Nerve Stimulation; balance; vestibular rehabilitation

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (3)

• Dizziness Handicap Inventory Scale

  5 minutes

• Tampa Kinesiophobia Scale

  5 minutes

• Hospital Anxiety and Depression Scale (HAD)

  5 minutes

Study Arms (2)

VR+VAGUS GROUP

EXPERIMENTAL

VR+VAGUS GROUP (n=20): PATIENTS USED NON-INVASIVE VAGUS NERVE STIMULATION IN ADDITION TO VESTIBULAR REHABILITATION

Device: non-invasive vagus nerve stimulation; Behavioral: vestibular rehabilitation

VR GROUP

ACTIVE COMPARATOR

VR GROUP (n=20) : PATİENTS UNDERGOİNG VESTİBULAR REHABİLİTATİON

Behavioral: vestibular rehabilitation

Interventions

non-invasive vagus nerve stimulation DEVICE

non-invasive vagus nerve stimulation: patients will receive non-invasive vagus nerve stimulation.

VR+VAGUS GROUP

vestibular rehabilitation BEHAVIORAL

vestibular rehabilitation: Patients will be given specially structured vestibular rehabilitation exercises.

VR GROUP; VR+VAGUS GROUP

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• He learned about unilateral peripheral vestibular hypofunction with videonystagmography
• Being able to communicate well

You may not qualify if:

• 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

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Istanbul Medipol University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Vestibular Diseases; Vertigo

Condition Hierarchy (Ancestors)

Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• tuğba türk kalkan, MD

  Medipol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: 40 patients diagnosed with UHV were included. 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 Record Dates

• First Submitted: March 14, 2024
• First Posted: March 27, 2024
• Study Start: October 15, 2021
• Primary Completion: April 15, 2024
• Study Completion: June 15, 2024
• Last Updated: March 25, 2025

Record last verified: 2025-03

Locations

TU (1)