To determine the sensitivity and specificity of the HINTS+ test in detecting a central cause in patients with acute onset, continuous dizziness in a general ED population, when performed by general neurologists/ED physicians.
ID
Source
Brief title
Condition
- Inner ear and VIIIth cranial nerve disorders
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint is final diagnosis by the expert panel after three months.
Secondary outcome
Secondary endpoints are health care costs, sensitivity/specificity of early
(<24-48 hours) and delayed (>72 hours and <10 days) MRI of the brain and of a
biomarker.
Background summary
Acute onset, continuous dizziness (AOCD, previously also known as isolated
vertigo) without focal neurological deficits is one of the most challenging
symptoms in the emergency department (ED). Most patients with these complaints
will have a benign disorder of the vestibular system. However, some patients
will suffer from a central problem, mostly stroke. The challenge in
differentiating between these diagnoses lies in the identical presentation.
AOCD is a very common symptom at the ED. It is assumed to represent 3% of all
ED visits in the United states. To emphasize the difficulty we have in
determining the correct diagnosis, approximately 130.000-200.000 strokes in all
these patients are missed each year. Conventional neurologic examination is
notoriously unreliable and CT imaging has a poor specificity and sensitivity.
MRI of the brain is thought to be the gold standard, even though 12% of
posterior circulation strokes could be missed if MRI is performed within 48
hours. This may even rise up to 23% if MRI is performed within 24 hours. The
HINTS+ test (Head Impulse, Nystagmus, Test of Skew and Hearing Loss) has been
proposed as a bedside test with an excellent sensitivity and specificity of
around 100% and 90% respectively to discriminate between a central and
peripheral cause. However, most of the studies regarding the HINTS+ test are
small sized and are performed in a small number of specialized tertiary
neuro-otology centers with highly selected patients. The external validation
has yet to be performed. Further research with more inclusive selection
paradigms is needed to validate the accuracy of the HINTS+ test and MRI in
AOCD. Moreover, other diagnostic tests should be taken into account (e.g. video
assisted HINTS+ test and biomarker investigation) to further improve diagnostic
accuracy in this patient population.
Study objective
To determine the sensitivity and specificity of the HINTS+ test in detecting a
central cause in patients with acute onset, continuous dizziness in a general
ED population, when performed by general neurologists/ED physicians.
Study design
A prospective multi-center cohort investigation.
Study burden and risks
The burden of this study is an extra questionnaire and a single venous
puncture. In a selected group of patients an extra MRI scan will be performed
(one group with gadolinium contrast and one group without gadolinium contrast).
Lijnbaan 32
Den Haag 2512 VA
NL
Lijnbaan 32
Den Haag 2512 VA
NL
Listed location countries
Age
Inclusion criteria
- Acute onset, continuous dizziness, still present at arrival on the ED as the
principal reason for the ED visit.
- Presentation within 24 hours after onset of dizziness.
- Age 18 years or older.
- For substudy 1: Presentation at the ED of one of the following centers:
Haaglanden Medical Center, Haga Hospital, Jeroen Bosch Hospital or Gelre
Hospital.
- For substudy 1: Early MRI DWI <48 hours of symptom onset without explanatory
lesion.
- For substudy 2: Presentation at the ED of the Haga Hospital.
- For substudy 2: Vestibular neuritis as most probable diagnosis as determined
by the treating physician on the ED, based on i.a. horizontal-torsional
nystagmus in one direction and positive HIT.
Exclusion criteria
- Clear signs of benign paroxysmal positional vertigo (BPPV) (i.e. acute onset,
continuous dizziness successfully treated by canalith repositioning).
- Recognizable recurrent vertigo or acute onset dizziness compatible with a
known previous diagnosis of Meniere*s disease or vestibular migraine;
- New deficits upon neurological examination (i.e. ataxia, dysarthria,
spontaneous skew deviation, gaze palsy or lowered state of consciousness (i.e.
Glasgow Coma Scale (GCS) score <14)). Nystagmus and gait imbalance are allowed.
- Known pregnancy at the time of inclusion.
- Known contra-indication for MRI (e.g. claustrophobia, non MRI-compatible
pacemaker or ICD).
- Clear medical condition other than a central or a peripheral vestibular
disorder that explains acute onset, continuous dizziness. Examples are
hypotension, sepsis, medication related.
- Previous inclusion in this study.
- Unable to undergo follow up (e.g. life expectancy <3 months, severe cognitive
impairment, no permanent residence in the Netherlands).
- Unable to give informed consent (e.g. cognitive impairment, mental
retardation).
- Insufficient command of the Dutch language.
- For substudy 2 additional exclusion criterium: known allergy to gadolinium.
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL76143.058.21 |
| Other | NL9197 |