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StrokeNCT02938221

Telemedical Examination of a Three-Component Oculomotor Testing Battery

A study testing Telemedical video-oculography system in people with Stroke and Vertigo, run by Munich Municipal Hospital at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Stroke, Vertigo, Dizziness
What is being tested?
Telemedical video-oculography system
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteGermany
Study dates
Oct 2016to Dec 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Consenting adults

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Klinikum München-Harlaching

    Munich, Bavaria, 81545

Other trials in Germany

About this study

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

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.

Being tested
Telemedical video-oculography system
Keywords
TeleStroke, HINTS, Diagnosis, Telemedicine, Acute Vestibular Syndrome
Medical subject headings
Stroke, Vertigo, Dizziness, Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Telemedical video-oculography systemDevice

    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)

Study groups in NCT02938221
Study groupRoleWhat they receive
Telemedical video-oculographyExperimentalExecution of three oculomotor tests using a telemedical video-oculography system
Receives: Device: Telemedical video-oculography system

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of evaluable telemedical oculomotor examinations

    Measured: through completion of diagnostic test, an average of 10 minutes

Secondary outcomes (3)

  1. Accuracy of telemedical oculomotor examination (correlation to bedside test)

    Measured: through completion of diagnostic test, an average of 10 minutes

  2. Number of participants with adverse or serious adverse events that are related to telemedical oculomotor examination

    Measured: through completion of diagnostic test, an average of 10 minutes

  3. Time delay of telemedical tests

    Measured: through completion of diagnostic test, an average of 10 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2016 (estimated)
  2. Study startOct 2016
  3. Primary completionDec 2016
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02938221
Sponsor's protocol ID
TeleHINTS-1
Status last verified
Jan 2017
First submitted
14 Oct 2016
Last updated
12 Jan 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 19762709

  • 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.

    PubMed 24127701

  • 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.

    PubMed 19645921

  • 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.

    PubMed 19805730

  • 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.

    PubMed 23463752

Questions about this trial

What is this clinical trial studying?

A study testing Telemedical video-oculography system in people with Stroke and Vertigo, run by Munich Municipal Hospital at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of evaluable telemedical oculomotor examinations (time frame: through completion of diagnostic test, an average of 10 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02938221, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2017.

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