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

Laval University

Status: Active, not recruiting

Conditions: Stroke, Acute; Nystagmus, Acquired

Treatments: Diagnostic Test: Diagnostic Algorithm; Device: Frenzel Lens

Study type: Interventional

Funder types: Other

Identifiers

NCT05176015

MP-CIBSSSBSL-2021-03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

120 participants in 4 patient groups

Frenzel Lens with Diagnostic Algorithm

Experimental group

Description:

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

Treatment:

Diagnostic Test: Diagnostic Algorithm

Device: Frenzel Lens

Frenzel Lens without Diagnostic Algorithm

Experimental group

Description:

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.

Treatment:

Device: Frenzel Lens

No Frenzel Lens with Diagnostic Algorithm

Experimental group

Description:

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

Treatment:

Diagnostic Test: Diagnostic Algorithm

No Frenzel Lens and No Diagnostic Algorithm

No Intervention group

Description:

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