AIVertigo: AIVertigo: Automated Differential Diagnosis of Vertigo Using Video-oculography and Advanced Artificial Intelligence-based Triage

Vertigo Clinical Trial

Official title:

AIVertigo: Automated Differential Diagnosis of Vertigo Using Video-oculography and Advanced Artificial Intelligence-based Triage

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06115915
• Other study ID #: 2020061901SAMD
• Status: Completed
• Start date: July 1, 2019
• Est. completion date: June 18, 2021

Study information

• Verified date: November 2023
• Source: Neurobit Technologies Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The eye movement records and vestibular pulse examinations obtained from patients with dizziness can provide characteristic parameters and features of eye movements and vestibular reflexes. These can assist specialized physicians in diagnosing various forms of dizziness disorders. Through extensive analysis of databases, a disease prediction model can be established, significantly lowering the diagnostic barriers for non-specialist doctors, thereby enabling their diagnostic capabilities to approach that of experts.

Description:

Investigators analyze the VOG and vHIT data of vertigo patients in the dizziness clinics of two medical institutions: Shuang Ho Hospital (SHH) between June 2020 and June 2021 and Taichung Tzu Chi Hospital (TTCH) between July 2019 and August 2020, respectively. The institutional review boards of SHH (TMU-JIRB No. N202005118) and TTCH (REC 109-64) approved the study. All patients received structuralized history taking, neurological examinations, neuro-otological examinations, VOG and vHIT. All patients who had focal neurological symptoms/signs or central vestibular/oculomotor signs underwent brain MRI. Final diagnoses were conducted after the comprehensive studies above. The patients who did not finish VOG tests or vHIT or who had invalid data in VOG or vHIT, as well as those with uncertain final diagnoses, were excluded from the study.

According to the final diagnoses, all patients were further classified into "benign vertigo" and "dangerous vertigo" groups as the reference standard of this study. Benign vertigo is defined as vertigo that is not caused by any serious underlying condition and is generally considered harmless or self-limiting. It includes all peripheral-type vertigo and "benign" central-type vertigo without structural lesions in the brain, such as vestibular migraine and persistent postural-perceptual dizziness. However, dangerous vertigo is defined as the vertigo that is caused by a potentially severe or life-threatening underlying condition that requires immediate medical attention and intervention. It includes central-type vertigo with compatible structural lesions in the brain MRI, vertebrobasilar insufficiency with compatible stenotic arteries in MRI, and cerebellar degeneration with brain atrophy in MRI or apparent cerebellar ataxia. The classification of benign or dangerous vertigo was performed by two neurologists with expertise in dizziness and vertigo at each medical institution (SHH and TTCH) after they reviewed the clinical information and final diagnoses. In case they had differing opinions, they reached a consensus via video conferences. Otherwise, the clinical workflow was in accordance with the standard procedures of each medical institution.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 391
• Est. completion date: June 18, 2021
• Est. primary completion date: June 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

Inclusion Criteria:

• Dizziness receiving medical treatment at the Neurology and Otolaryngology departments' outpatient clinics including cases transferred from the emergency department to outpatient clinics.

• Inpatient wards (including cases transferred from the emergency department to hospitalization) of the Neurology and Otolaryngology departments.

Exclusion Criteria:

• With prosthetic eyes.

• Uncorrected visual acuity below 0.1.

• Severe hearing or cognitive impairments preventing examination.

• Severe cervical spine conditions precluding examination.

• Unable to sit for prolonged periods.

Related Conditions & MeSH terms

• Dizziness
• Vertigo

Locations

Country	Name	City	State
Taiwan	Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare	New Taipei City

Sponsors (3)

Lead Sponsor	Collaborator
Neurobit Technologies Co., Ltd.	Buddhist Tzu Chi Medical Foundation, Taipei Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance Indices	Sensitivity, specificity, positive predictive value, and negative predictive value of combined parameters of eye movement and vestibular reflex in screening various types of vestibular disorders.; Sensitivity, specificity, positive predictive value, and negative predictive value of combined parameters of eye movement and vestibular reflex in screening various types of vestibular disorders cross different medical institution	2 hour per individual