Nystagmus Assessment for Patients Consulting in the Emergency Department for Acute Vertigo

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-15

Study Completion Date

2024-10-31

Brief Summary

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This pilot study is perfomed to validate and document faisability of the use of Frenzel lens and the use of a diagnostic algorithm for the assessment of a special sign (nystagmus) observe in the eyes of patients consulting in the emergency department (ED) for an acute episode of vertigo/dizziness/imbalance.

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Detailed Description

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This pilot study is a randomized controlled trial 2 by 2 design to allocated randomly the Frenzel lens and the diagnostic algorithm. There is no use of sham lens. The usual care opposed to the diagnostic algorithm will be questioned only on the perception of nystagmus by the clinician and the use of repositioning particles technique. The only blinding will be the patients about the use of the algorithm and the outcomes assessor about the use or not of Frenzel lens and the use or not of the diagnostic algorithm.

Conditions

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Nystagmus, Acquired Stroke, Acute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Frenzel Lens with Diagnostic Algorithm

Frenzel lens will be applied on patients' eyes during different diagnostic maneuvers to assess if a nystagmus is present and if present describe its main characteristic.

Without mentioning to patient, the emergency physician will use a diagnostic algorithm inspired from the TiTrATE approach to interpret the nystagmus and propose the need or the irrelevance for neuro-imaging

Group Type EXPERIMENTAL

Frenzel Lens

Intervention Type DEVICE

pair of magnifying glasses (+20 dioptres) that are worn by the patient and an illuminating system. On using Frenzel goggles, the nystagmus is better seen as a result of eyes being magnified and inhibition of visual fixation.

Diagnostic Algorithm

Intervention Type DIAGNOSTIC_TEST

A diagnostic algorithm using the TiTrate approach: continuous, Intermittent, trigger or spontaneous.

The diagnostic algorithm use the REDCap software that include different videos to illustrate diagnostic tests and nystagmus types. Different maneuvers: HINTS+ battery, Dix-Hallpike test, Supine Roll test.

Different Particle Repositioning Techniques will be proposed according to specific tests: Epley and Gufoni maneuvers.

Risk Score is used to assess stroke risk for transient ischaemic attack (TIA): ABCD2 and the Canadian TIA Risk Score

Frenzel Lens without Diagnostic Algorithm

Frenzel lens will be applied on patients' eyes during different diagnostic maneuvers to assess if a nystagmus is present and describe its main characteristics. No diagnostic algorithm will be used to interpret nystagmus.

Group Type EXPERIMENTAL

Frenzel Lens

Intervention Type DEVICE

pair of magnifying glasses (+20 dioptres) that are worn by the patient and an illuminating system. On using Frenzel goggles, the nystagmus is better seen as a result of eyes being magnified and inhibition of visual fixation.

No Frenzel Lens with Diagnostic Algorithm

Nystagmus assessment in different manoeuvres is performed without the use of Frenzel lens.

Without mentioning to patient, the emergency physician will use a diagnostic algorithm inspired from the TiTrATE approach to interpret the nystagmus and propose the need or the irrelevance for neuro-imaging

Group Type EXPERIMENTAL

Diagnostic Algorithm

Intervention Type DIAGNOSTIC_TEST

A diagnostic algorithm using the TiTrate approach: continuous, Intermittent, trigger or spontaneous.

The diagnostic algorithm use the REDCap software that include different videos to illustrate diagnostic tests and nystagmus types. Different maneuvers: HINTS+ battery, Dix-Hallpike test, Supine Roll test.

Different Particle Repositioning Techniques will be proposed according to specific tests: Epley and Gufoni maneuvers.

Risk Score is used to assess stroke risk for transient ischaemic attack (TIA): ABCD2 and the Canadian TIA Risk Score

No Frenzel Lens and No Diagnostic Algorithm

The emergency physician is performing the assessment of nystagmus and its interpretation as usual. The Frenzel lens and the diagnostic algorithm are not used.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Frenzel Lens

pair of magnifying glasses (+20 dioptres) that are worn by the patient and an illuminating system. On using Frenzel goggles, the nystagmus is better seen as a result of eyes being magnified and inhibition of visual fixation.

Intervention Type DEVICE

Diagnostic Algorithm

A diagnostic algorithm using the TiTrate approach: continuous, Intermittent, trigger or spontaneous.

The diagnostic algorithm use the REDCap software that include different videos to illustrate diagnostic tests and nystagmus types. Different maneuvers: HINTS+ battery, Dix-Hallpike test, Supine Roll test.

Different Particle Repositioning Techniques will be proposed according to specific tests: Epley and Gufoni maneuvers.

Risk Score is used to assess stroke risk for transient ischaemic attack (TIA): ABCD2 and the Canadian TIA Risk Score

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* New episode of acute vertigo/dizziness/imbalance occuring during the 28 last days
* Must be able to consent.

Exclusion Criteria

* No traumatic context before symptoms onset
* No intoxication context
* Glycemia ≤ 3,0 mmol/L
* Only one participation is permitted
* Not able to speak adequately in French or English.
* Reachable for 3 month follow-up

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No