The main objective of this study is to gain more insight into the possible role of the vestibular system in the observed acute effects on neurocognitive and postural stability due to movement in the static magnetic stray fields of MRI scanners. In…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Gezonde vrijwilligers
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The test battery will be the same as in our previous MRI-experiment and
consists of 13 tests for e.g. sensory and motor functioning, haptic perception,
attention, concentration, orientation, working memory and postural stability
Secondary outcome
n/a
Background summary
Previous studies showed acute transient neurocognitive and postural stability
effects of torso and head movements within the static magnetic stray field of a
1.5 T, 3 T and 7 T MRI scanners. These effects probably arise due to induced
electrical currents that are generated during such movements. Surgeons and
radiologists working close to MRI systems need to maintain a high level of
accuracy in neurocognitive and postural performance. Therefore, understanding
of the mechanisms of the observed acute effects is highly relevant for the
development of appropriate safety procedures in practice. We intend to further
investigate the biological mechanisms involved by investigating the potential
role of the vestibular system in evoking the observed acute effects.
Study objective
The main objective of this study is to gain more insight into the possible role
of the vestibular system in the observed acute effects on neurocognitive and
postural stability due to movement in the static magnetic stray fields of MRI
scanners. In order to achieve this objective we will compare our earlier
reported neurocognitive and postural effects of exposure to movements in the
static magnetic fields near MRI scanners with effects of exposure to Galvanic
Vestibular Stimulation (GVS), a known procedure which directly stimulates the
vestibular system.
Study design
Single blind randomised crossover design
Study burden and risks
Subjects will be exposed to two experimental conditions; a sham condition and
an exposure condition with ~20 seconds of continuous GVS at 0.7 mA before each
single test within the test battery. Simultaneous to GVS stimulation,
standardised head movement will be made to have similar sensory input between
this and the previous MRI-experiment.
First a training session is administered (to explain the procedure and reduce
practice effects) followed after a 15 minutes break by the two exposure
sessions in random order. The visit will take 4 hours in total; one hour for
each session and an hour break in between the two test sessions. Before and
after each test session a short questionnaire will be completed. If potential
short-term effects occur, such as vertigo and nausea, they are expected to last
for a few minutes. No long-term effects of the GVS exposure are known. A
travelling allowance and a financial gift voucher of sixty euro*s for the
completed experiment will be provided.
Jenalaan 18D
3584 CK Utrecht
NL
Jenalaan 18D
3584 CK Utrecht
NL
Listed location countries
Age
Inclusion criteria
Healthy
Men and women
between 18 and 65 year
Exclusion criteria
Vulnerability to motionsickness
Neurological or psychiatric disorders (past or present)
Drug use in the last 4 weeks (except of contraconception)
Design
Recruitment
Medical products/devices used
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 | NL39451.041.12 |