The objective of this study is to examine the vestibular system in three dimensions. To achieve this goal three experiments are performed. The EyeSeeCam video-oculography is validated with the scleral search coils (international golden standard).…
ID
Source
Brief title
Condition
- Inner ear and VIIIth cranial nerve disorders
- Nervous system neoplasms benign
- Nervous system, skull and spine therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Experiment 1: The determination of the reference range of the VOR in different
methods
Experiment 2: The difference in gain and misallignement of the VOR; before and
after treatment.
Experiment 3: The effect of head angle on the gain and misalligment of the VOR.
Secondary outcome
not applicable
Background summary
The vestibular system is important in everyday life. The three semi-circular
canals regulate compensatory eye movements, equal and opposite to head movement
to reserve the gaze. This is called the Vestibulo-Ocular Reflex, or VOR. Damage
of this system, as with a Acoustic Neuroma, may cause dizziness, unsteadiness
of gait and vertigo.
Current methods for evaluating vestibular impairment are quick, easy to do and
non-invasive. A disadvantage however is the fact that only the horizontal
canals are examined. Moreover, the rotational chair test measures the VOR only
at low frequencies and patients describe the caloric test as aggravating.
Study objective
The objective of this study is to examine the vestibular system in three
dimensions. To achieve this goal three experiments are performed. The EyeSeeCam
video-oculography is validated with the scleral search coils (international
golden standard). Using these glasses, new vestibular function tests used in
the clinic can be validated. Experiments 2 and 3 are more fundamental, for
which the scleral search coil is used to measure the VOR in three dimensions.
In experiment 2 the three dimensional VOR is mesasured in patients with an
untreated unilateral acoustic neuroma.
And in the third experiment, we want to measure the three dimensional VOR
during rotations at different angles of the head, including the angle at which
the horizontal canals are equal to earth's horizontal.
Study design
The VOR will be measured in three experiments:
Experiment 1 is an observational study in which the VOR of healthy subjects and
patiënts with vestibular impairment are tested using Video-Oculography.
Experiment 2 is a prospective study in which the VOR of patients with
unilateral acoustic neuromas are measured in three dimensions using scleral
search coils.
Experiment 3 is an observational study, in which the VOR is tested in healthy
subjects in three dimension using scleral search coils. The subjects will be
measured in 5 different angles of the head.
Study burden and risks
Experiment 1: The patients and healthy subjects are measured for 15 minutes.
Different clinical methods will be performed using the Video-Oculography. The
experiment will be planned right before or after the hospital appointment.
Experiment 2: The patients are measured twice (before and after treatment)
during half an hour. With all preperations the appointment will take about two
hours both times. Before the scleral search coil is applied, the eye will be
anaesthetized using oxybuprocaïne-eyedrops.
Experiment 3: The healthy subjects are measured once during an appointment of
two hours. The five different angles are measured during half an hour. Before
the scleral search coil is applied, the eye will be anaesthetized using
oxybuprocaïne-eyedrops.
Dr. Molewaterplein 50
Rotterdam 3015 GE
NL
Dr. Molewaterplein 50
Rotterdam 3015 GE
NL
Listed location countries
Age
Inclusion criteria
Absence of neurological disease and complaints of vertigo (except for the acoustic neuroma which is present at the patientgroup), no drugs or alcohol abuse 6 months prior to the study, no history of 'closed head injury', age above 18 years and a signed informed consent.
Exclusion criteria
Neurological or psychiatric disease, vertigo complaints, drugs or alcohol abuse less than 6 months prior to the study, history including 'closed head injury', underaged (< 18 years)
Design
Recruitment
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 | NL46573.078.13 |