Telemedical Examination of a Three-Component Oculomotor Testing Battery
Primary Purpose
Stroke, Vertigo, Dizziness
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Telemedical video-oculography system
Sponsored by
About this trial
This is an interventional diagnostic trial for Stroke focused on measuring TeleStroke, HINTS, Diagnosis, Telemedicine, Acute Vestibular Syndrome
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
Sites / Locations
- Klinikum München-Harlaching
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Telemedical video-oculography
Arm Description
Execution of three oculomotor tests using a telemedical video-oculography system
Outcomes
Primary Outcome Measures
Number of evaluable telemedical oculomotor examinations
Secondary Outcome Measures
Accuracy of telemedical oculomotor examination (correlation to bedside test)
Number of participants with adverse or serious adverse events that are related to telemedical oculomotor examination
Time delay of telemedical tests
Full Information
NCT ID
NCT02938221
First Posted
October 14, 2016
Last Updated
January 11, 2017
Sponsor
Munich Municipal Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02938221
Brief Title
Telemedical Examination of a Three-Component Oculomotor Testing Battery
Official Title
Feasibility and Safety of a Telemedically Performed Three-Component Oculomotor Testing Battery (HINTS) in Healthy Adults
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
October 2016 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Munich Municipal Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Vertigo, Dizziness
Keywords
TeleStroke, HINTS, Diagnosis, Telemedicine, Acute Vestibular Syndrome
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Telemedical video-oculography
Arm Type
Experimental
Arm Description
Execution of three oculomotor tests using a telemedical video-oculography system
Intervention Type
Device
Intervention Name(s)
Telemedical video-oculography system
Intervention Description
Telemedical video-oculography setup consisting of video goggles (EyeSeeCam, Interacoustics GmbH, Germany), a mobile telemedical workstation and an extended conferencing and remote control system (MEYTEC GmbH, Germany)
Primary Outcome Measure Information:
Title
Number of evaluable telemedical oculomotor examinations
Time Frame
through completion of diagnostic test, an average of 10 minutes
Secondary Outcome Measure Information:
Title
Accuracy of telemedical oculomotor examination (correlation to bedside test)
Time Frame
through completion of diagnostic test, an average of 10 minutes
Title
Number of participants with adverse or serious adverse events that are related to telemedical oculomotor examination
Time Frame
through completion of diagnostic test, an average of 10 minutes
Title
Time delay of telemedical tests
Time Frame
through completion of diagnostic test, an average of 10 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gordian J Hubert, Dr. med.
Organizational Affiliation
Städtisches Klinikum München GmbH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinikum München-Harlaching
City
Munich
State/Province
Bavaria
ZIP/Postal Code
81545
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
19762709
Citation
Kattah JC, Talkad AV, Wang DZ, Hsieh YH, Newman-Toker DE. HINTS to diagnose stroke in the acute vestibular syndrome: three-step bedside oculomotor examination more sensitive than early MRI diffusion-weighted imaging. Stroke. 2009 Nov;40(11):3504-10. doi: 10.1161/STROKEAHA.109.551234. Epub 2009 Sep 17.
Results Reference
background
PubMed Identifier
24127701
Citation
Newman-Toker DE, Kerber KA, Hsieh YH, Pula JH, Omron R, Saber Tehrani AS, Mantokoudis G, Hanley DF, Zee DS, Kattah JC. HINTS outperforms ABCD2 to screen for stroke in acute continuous vertigo and dizziness. Acad Emerg Med. 2013 Oct;20(10):986-96. doi: 10.1111/acem.12223.
Results Reference
background
PubMed Identifier
19645921
Citation
Bartl K, Lehnen N, Kohlbecher S, Schneider E. Head impulse testing using video-oculography. Ann N Y Acad Sci. 2009 May;1164:331-3. doi: 10.1111/j.1749-6632.2009.03850.x.
Results Reference
background
PubMed Identifier
19805730
Citation
MacDougall HG, Weber KP, McGarvie LA, Halmagyi GM, Curthoys IS. The video head impulse test: diagnostic accuracy in peripheral vestibulopathy. Neurology. 2009 Oct 6;73(14):1134-41. doi: 10.1212/WNL.0b013e3181bacf85.
Results Reference
background
PubMed Identifier
23463752
Citation
Newman-Toker DE, Saber Tehrani AS, Mantokoudis G, Pula JH, Guede CI, Kerber KA, Blitz A, Ying SH, Hsieh YH, Rothman RE, Hanley DF, Zee DS, Kattah JC. Quantitative video-oculography to help diagnose stroke in acute vertigo and dizziness: toward an ECG for the eyes. Stroke. 2013 Apr;44(4):1158-61. doi: 10.1161/STROKEAHA.111.000033. Epub 2013 Mar 5.
Results Reference
background
Learn more about this trial
Telemedical Examination of a Three-Component Oculomotor Testing Battery
We'll reach out to this number within 24 hrs