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Clinical Trials/NCT02938221
NCT02938221
Completed
Not Applicable

Feasibility and Safety of a Telemedically Performed Three-Component Oculomotor Testing Battery (HINTS) in Healthy Adults

Munich Municipal Hospital1 site in 1 country30 target enrollmentOctober 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Munich Municipal Hospital
Enrollment
30
Locations
1
Primary Endpoint
Number of evaluable telemedical oculomotor examinations
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2016
End Date
December 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Munich Municipal Hospital
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Number of evaluable telemedical oculomotor examinations

Time Frame: through completion of diagnostic test, an average of 10 minutes

Secondary Outcomes

  • 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)
  • Time delay of telemedical tests(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)

Study Sites (1)

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