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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06332326
Enrollment
40
Registered
2024-03-27
Start date
2021-10-15
Completion date
2024-06-15
Last updated
2025-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vestibular Diseases, Vestibular Vertigo, Vertigo

Keywords

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

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).

Interventions

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

BEHAVIORALvestibular rehabilitation

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

Sponsors

Medipol University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Intervention model description

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).

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Dynamic visual acuity test5 minutesDynamic visual acuity test; It measures the ability to see an object during rapid head movements.
Unterberger test5 minutesUnterberger 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.
one-leg standing test10 minutesone-leg standing test; The conditions (sec) of remaining in balance with eyes open and closed on hard and soft surfaces will be measured.
VAS Visual Analogue Scale (dizziness severity)5 minutesVisual 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.
Modified-CTSIB30 minutesModified-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.
Semitandem test10 minutessemitandem stance positions; The conditions (sec) of remaining in balance with eyes open and closed on hard and soft surfaces will be measured.
tandem test10 minutestandem semitandem stance positions; The conditions (sec) of remaining in balance with eyes open and closed on hard and soft surfaces will be measured.

Secondary

MeasureTime frameDescription
Tampa Kinesiophobia Scale5 minutesThe 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 minutesThe 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 Scale5 minutesIt 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026