Telemedical Examination of a Three-Component Oculomotor Testing Battery

Not Applicable

Completed

• Conditions: Stroke; Dizziness; Vertigo
• Interventions: Device: Telemedical video-oculography system

• Registration Number: NCT02938221
• Lead Sponsor: Munich Municipal Hospital

Brief Summary

The study investigates the feasibility and safety of the telemedical implementation of three diagnostic oculomotor tests using a video-oculography device and an extended teleconferencing system. The testing battery comprises Halmagyi's head impulse test, test for nystagmus and test of skew (vertical misalignment) known as the HINTS protocol. Previously published data have shown high sensitivity and specificity of the protocol for the discrimination of central and peripheral causes of acute vestibular syndrome. In this study the three tests will be executed on 30 healthy subjects using video goggles (EyeSeeCam, Interacoustics GmbH, Germany) connected to a mobile wireless-workstation for bidirectional audiovisual communication in a clinical environment (MEYTEC GmbH, Germany). A newly developed remote control and video conferencing solution allows the execution and evaluation of the HINTS protocol in a telemedical setup.

The examination is guided by a remote physician using the help of a trained assistant attending to the subject. Corresponding clinical bedside tests will be executed for comparison. Primary endpoint is feasibility of the three diagnostic tests in a telemedical setting. Safety as well as accuracy of the telemedical versus bedside examination will be analyzed as secondary outcome measures. Aim of the study is to improve diagnostic accuracy for patients with acute vestibular syndrome in remote areas where specialists are rare.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-10-14
• Study First Submitted QC: 2016-10-17
• Study First Posted: 2016-10-19
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-11
• Last Update Posted: 2017-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Consenting adults

Exclusion Criteria

• Acute vertigo or dizziness, acute neck pain, history of stroke, history of acute vestibular syndrome, strong unilateral or bilateral visual impairment, complete movement restriction of cervical spine

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Telemedical video-oculography	Telemedical video-oculography system	Execution of three oculomotor tests using a telemedical video-oculography system

Primary Outcome Measures

Name	Time	Method
Number of evaluable telemedical oculomotor examinations	through completion of diagnostic test, an average of 10 minutes

Secondary Outcome Measures

Name	Time	Method
Time delay of telemedical tests	through completion of diagnostic test, an average of 10 minutes
Number of participants with adverse or serious adverse events that are related to telemedical oculomotor examination	through completion of diagnostic test, an average of 10 minutes
Accuracy of telemedical oculomotor examination (correlation to bedside test)	through completion of diagnostic test, an average of 10 minutes

Trial Locations

Locations (1)

Klinikum München-Harlaching; 🇩🇪 Munich, Bavaria, Germany