The primary objective is to clarify the frequency of t-BPPV in patients after mild TBI. Secondary objectives are: assessment of the symptoms of t-BPPV and the treatment success of t-BPPV.
ID
Source
Brief title
Condition
- Inner ear and VIIIth cranial nerve disorders
- Head and neck therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter is the frequency of t-BPPV after mild TBI.
Secondary outcome
Secondary study parameters are: 1. The symptoms and characteristics of t-BPPV.
2. The treatment success of CRM treatment in terms of resolution of symptoms
and the recurrence rate after one year follow up in patients with t-BPPV.
Background summary
Benign Paroxysmal Positional Vertigo (BPPV) is one of the most common
vestibular disorders. Patients with BPPV suffer from vertigo after movements of
the head, increasing the risk of falling. BPPV can be very effectively treated
by a canalith repositioning manoeuvre (CRM). The majority of cases of BPPV is
idiopathic. Secondary BPPV can be related to traumatic brain injury (TBI) or
inner ear disorders. Dizziness affects a large proportion of head injured
patients and may persist for many years after the injury. Therefore, it is
important to investigate ways to facilitate early diagnosis and management of
dizziness and imbalance after head injury and identify the patients suffering
from traumatic-BPPV (t-BPPV). Currently there is no data on the frequency and
type of BPPV in acute TBI and contradictory data about the recurrence of
t-BPPV. The main aim of this study is to accurately determine the frequency of
BPPV after TBI. Secondary aims are to address: (1) the symptoms and
characteristics of t-BPPV. Is there a **subclinical** type of BPPV (without
symptoms)? (2) determine the treatment success of t-BPPV and (3) determine the
recurrence rate of t-BPPV. We hypothesize that the frequency of BPPV is higher
after a TBI than reported in previous studies, because of underdiagnosis and
absence of symptoms.
Study objective
The primary objective is to clarify the frequency of t-BPPV in patients after
mild TBI. Secondary objectives are: assessment of the symptoms of t-BPPV and
the treatment success of t-BPPV.
Study design
A prospective, single-center, observational cohort study.
Intervention
All patients will be tested for t-BPPV by means of Dix-Hallpike and Supine roll
tests and treated if necessary with a CRM.
Study burden and risks
If patients consent to enter the study, they will be invited to visit the
ENT/Neurology department of Gelre Hospital one week after trauma. The included
patients will be asked to fill in two questionnaires regarding their symptoms,
the severity of vertigo and the impact of dizziness on their quality of life.
Patients will be tested for BPPV by means of Dix-Hallpike and Supine roll
tests. All patients with confirmed t-BPPV will be treated with a CRM. There
will be an one year follow up after trauma. No other extra procedures will be
performed for the study (no invasive procedures, clinical tests, laboratory
tests etc.).
Albert Schweitzerlaan 31
Apeldoorn 7334 DZ
NL
Albert Schweitzerlaan 31
Apeldoorn 7334 DZ
NL
Listed location countries
Age
Inclusion criteria
- Older than 18 years
- Mild traumatic brain injury (with or without a CT scan)
Exclusion criteria
- Patient does not speak English or Dutch
- Cervical spine ligament injury or fracture
Design
Recruitment
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 | NL75988.058.20 |