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

Randomized Controlled Trial on Nystagmus Assessment for Patients Consulting for Acute Vertigo in the Emergency Department With/Without Frenzel Lens With/Without Form: A Pilot Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Stroke, Acute; Nystagmus, Acquired
• Intervention / Treatment: Device: Frenzel Lens; Diagnostic test: Diagnostic Algorithm

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pierre La Rochelle, MD, MSc; Phone Number: 418-856-7000; Email: pierre.la-rochelle.med@ssss.gouv.qc.ca

Study Locations

• Canada
  • Quebec
    • Amqui, Quebec, Canada, G5J 2K5
      • Centre Hospitalier d'Amqui
    • La Pocatiere, Quebec, Canada, G0R 1Z0
      • Hopital Notre-Dame-de-Fatima
    • Matane, Quebec, Canada, G4W 2W5
      • Centre Hospitalier de Matane
    • Montmagny, Quebec, Canada, G5V 3R8
      • Centre Hospitalier de Montmagny
    • St-Georges, Quebec, Canada, G5Y4T8
      • Hopital St-Georges

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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	Device: 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.; Diagnostic test: 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
Experimental: 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.	Device: 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.
Experimental: 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	Diagnostic test: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of neuro-imaging per participant	Any imaging to investigate acute intra-cerebral lesion and/or the neck/brain vascular. anomaly : computed tomography imaging; computed tomography angiogram; magnetic resonance angiography; magnetic resonance imaging, vascular neck ultrasound imaging.	From day 0 to 12 weeks
Rate of acute vertigo/dizziness/imbalance related hospitalisation per participant	Admission to hospital directly related to vertigo/dizziness/imbalance may be immediate to initial visit or delayed.	From day 0 to 12 weeks
Rate of New Stroke at 12 weeks	A stroke free status will be assessed by a validated questionnaire by telephone at tree months and all specialised consultations and neuroimaging will be reviewed for acute stroke diagnosis,	At 12 weeks
Initial managment self appreciation of patient presenting in the ED for an acute episode of vertigo/dizziness/imbalance	Simple question answered on a likert scale at the end of the ED encounter. 0% worst, 100% best appreciation.	Day 0
Adverse Events	Combination of stroke, death, neurosurgery, intervenional neuroradiology, thrombolytic therapy	From day 0 to 12 weeks
Emergency Department Length of stay	Time spent at the emergency department from triage to time of departure for hospital admission or for home discharge assessed up to 48 hours	Day 0, from triage time to Emergency Department departure (admission or home discharge)
Rate of acute stroke per participant	Any acute stroke, hemorrhagic or ischemic, diagnosed by neuro-imaging: computed tomography or magnetic resonance imaging	From day 0 to 12 weeks
Rate of symptomatic central lesion per participant	Any central lesion diagnosed by computed tomography or magnetic resonance imaging that may be related to the initial presentation of vertigo/dizziness/imbalance	From day 0 to 12 weeks
Rate of specialised consultations for vertigo/dizziness/imbalance per participant	Any specialised consultations (neurology, ear nose and throat (ENT), cardiology or similar) to investigate the acute vertigo/dizziness/imbalance with the final diagnosis. Sumarisation of final diagnosis.	From day 0 to 12 weeks
Rate of subsequent Emergency Department Visit for Vertigo/dizziness/imbalance per participant	Return visit to the emergency department for vertigo/dizziness/imbalance as chief complaint.	From day 0 t0 12 weeks
Rate of New Atrial Fibrillation	Atrial fibrillation detected by the initial visit electrocardiogram or by long-term cardiac rhythm monitoring (Holter or loop recorder).	From day 0 to 12 weeks
Rate of the use of Particles Repositioning Technique	Once Paroxysmal Positional Vertigo diagnosis is being diagnosed with the Dix-Hallpike test or with the Supine Head Roll test, the use of particles repositioning technique, Epley or Gufoni maneuvers, will be noted with their immediate impact on acute vertigo.	Day 0
Rate of Emergency Department Visit Return for Benign Paroxysmal Positional Vertigo according to Typical Nystagmus	Rate of Emergency Department Visit Return for Benign Paroxysmal Positional Vertigo according to Typical Nystagmus: direction, duration	From day 0 to 12 weeks

Collaborators and Investigators

• Sponsor: CHU de Quebec-Universite Laval
• Investigators: Principal Investigator: Pierre La Rochelle, MD, MSc, Universite Laval

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2022
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): October 31, 2024

Study Registration Dates

• First Submitted: October 19, 2021
• First Submitted That Met QC Criteria: December 28, 2021
• First Posted (Actual): January 4, 2022

Study Record Updates

• Last Update Posted (Actual): April 25, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: stroke; neuroimaging; cardiovascular disease; nystagmus; benign positional paroxystic vertigo
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Disease Attributes; Otorhinolaryngologic Diseases; Labyrinth Diseases; Ear Diseases; Cranial Nerve Diseases; Vestibular Diseases; Sensation Disorders; Ocular Motility Disorders; Stroke; Emergencies; Vertigo; Dizziness; Nystagmus, Pathologic
• Other Study ID Numbers: MP-CIBSSSBSL-2021-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No