A randomized, single-blind, parallel prospective confirmatory clinical trial to compare and evaluate the efficacy of galvanic vestibular stimulation (GVS) on vestibular compensation and spatial cognitive function in patients with acute and chronic unilateral or bilateral vestibular dysfunctio
- Conditions
- Diseases of the ear and mastoid process
- Registration Number
- KCT0007058
- Lead Sponsor
- Jeonbuk National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 90
A. Patients who meet the diagnostic criteria for acute unilateral vestibular dysfunction (Acute UVD)
B. Chronic unilateral vestibular dysfunction (Chronic UVD) Patients who meet the following criteria
C. Patients who meet the diagnostic criteria for bilateral vestibular dysfunction (BVD)
D. Those who have a history of causing vestibular dysfunction and cognitive decline or have no history of neurodegenerative diseases such as stroke or dementia
E. A person who can understand the research contents, follow instructions, and can communicate
F. Those who consented to participation in the study and follow-up
G. 20 years old or older and less than 70 years old
A. Those who show abnormal findings in neurological examination
B. A person with a structural abnormality of the brain
C. There are other clinically serious diseases (cerebrovascular disease, cardiopulmonary disease, liver disease, kidney disease, malignancy, musculoskeletal disease, psychiatric disease and neurodegenerative disease that can affect cognitive function)
D. Those who are taking medications for epilepsy or have a history of convulsions
E. Women of childbearing potential and pregnant women
F. Persons with dermatological diseases, scars, or trauma at the site of application of the medical device
G. Persons who have installed metal devices inside and outside the body (considering those who cannot take MRI)
H. Those who do not agree to participate in the research
I. Subjects who participated in similar clinical trials within the last year
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluating the difference in gain and corrective saccade pattern in the vestibular function test (vHIT), the result value of the spatiotemporal function cognitive function test (VOSP, Corsi block test), and the fMRI signal change according to whether galvanic vestibular stimulation was performed.
- Secondary Outcome Measures
Name Time Method Check the following differences according to the left and right directions ; Gain and corrective saccades in the vestibular function test (vHIT), Result of spatiotemporal function cognitive function test (VOSP, Corsi block test) and fMRI signal change