Telemedical Examination of a Three-Component Oculomotor Testing Battery

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02938221
• Other study ID #: TeleHINTS-1
• Status: Completed
• Phase: N/A
• First received: October 14, 2016
• Last updated: January 11, 2017
• Start date: October 2016
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: Munich Municipal Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: German Institute of Medical Documentation and Information
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Dizziness
• Stroke
• Vertigo

Intervention

Device:
• Telemedical video-oculography system
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)

Locations

Country	Name	City	State
Germany	Klinikum München-Harlaching	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Munich Municipal Hospital

Country where clinical trial is conducted

Germany, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of evaluable telemedical oculomotor examinations		through completion of diagnostic test, an average of 10 minutes	No
Secondary	Accuracy of telemedical oculomotor examination (correlation to bedside test)		through completion of diagnostic test, an average of 10 minutes	No
Secondary	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	Yes
Secondary	Time delay of telemedical tests		through completion of diagnostic test, an average of 10 minutes	No