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

NCT05176015 | Completed

• 1 other identifier: MP-CIBSSSBSL-2021-03
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Nystagmus, Acquired; Stroke, Acute

Keywords

nystagmus; stroke; neuroimaging; cardiovascular disease; benign positional paroxystic vertigo

Outcome Measures

Primary Outcomes (1)

• Rate of Nystagmus detection per participant

  During eye examination, nystagmus will be characterized according to prominent direction of the fast phase (patients' left, patients' right, up, down, rotational),with their clinical setting or trigger. Overall rate of nystagmus detection by participant. (Rate of typical nystagmus for benign paroxysmal positional vertigo in the Dix-Hallpike maneuver or Supine Head Roll Test. Rate of nystagmus detection in the initial physical exam)

  Day 0

Secondary Outcomes (13)

• Emergency Department Length of stay

  Day 0, from triage time to Emergency Department departure (admission or home discharge)

• Rate of neuro-imaging per participant

  From day 0 to 12 weeks

• Rate of acute stroke per participant

  From day 0 to 12 weeks

• Rate of symptomatic central lesion per participant

  From day 0 to 12 weeks

• Rate of specialised consultations for vertigo/dizziness/imbalance per participant

  From day 0 to 12 weeks

Study Arms (4)

Frenzel Lens with Diagnostic Algorithm

EXPERIMENTAL

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

Device: Frenzel Lens; Diagnostic Test: Diagnostic Algorithm

Frenzel Lens without Diagnostic Algorithm

EXPERIMENTAL

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.

Device: Frenzel Lens

No Frenzel Lens with Diagnostic Algorithm

EXPERIMENTAL

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

Diagnostic Test: Diagnostic Algorithm

No Frenzel Lens and No Diagnostic Algorithm

NO INTERVENTION

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

Interventions

Frenzel Lens 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.

Frenzel Lens with Diagnostic Algorithm; Frenzel Lens without Diagnostic Algorithm

Diagnostic Algorithm 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 with Diagnostic Algorithm; No Frenzel Lens with Diagnostic Algorithm

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• CHU de Quebec-Universite Laval: lead

Study Sites (5)

Centre Hospitalier d'Amqui

Amqui, Quebec, G5J 2K5, Canada

Location

Centre Hospitalier de Matane

Matane, Quebec, G4W 2W5, Canada

Location

Centre Hospitalier de Montmagny

Saint Thomas de Montmagny, Quebec, G5V 3R8, Canada

Location

Hopital St-Georges

Saint-Georges, Quebec, G5Y4T8, Canada

Location

Hopital Notre-Dame-de-Fatima

Ste. Anne de la Pocatière, Quebec, G0R 1Z0, Canada

Location

MeSH Terms

Conditions

Nystagmus, Pathologic; Stroke; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Ocular Motility Disorders; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases

Study Officials

• Pierre La Rochelle, MD, MSc

  Universite Laval

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Investigator

Study Record Dates

• First Submitted: October 19, 2021
• First Posted: January 4, 2022
• Study Start: January 15, 2022
• Primary Completion: February 10, 2025
• Study Completion: February 10, 2025
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (5)