Primary Objective: To measure cortical spreading depression with full-band EEG during the migraine attack at patients aged 4 years or older. Secondary Objective(s): -To explore (additional) signal analysis techniques for detecting CSDs or infra slow…
ID
Source
Brief title
Condition
- Headaches
- Age related factors
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure will be the number of persons with spreading
depolarisations and/or infra slow activity during the migraine attack, which
are not present at the control EEG.
EEG will be analysed partially visually and partially by computer. Pathological
EEG results as CSD and ISA will be measured dichotomous as *present* and
*absent*, and will be quantified in frequency and amplitude. Mann-Whitney-U
test will be used to determine the difference in ISA and CSD presence between
the cases and controls.
Secondary outcome
To investigate the secondary objectives, the endpoints described as primary
endpoint will be necessary. No extra actions will be performed.
Background summary
The juvenile head trauma syndrome (JHTS) describes a rare phenomenon seen in
children. After a mild traumatic brain injury (mTBI), neurological symptoms of
drowsiness, a decreased consciousness, confusion, nausea and vomiting,
blindness, hemiparesis, and/or seizures appear. The pathophysiology of JHTS is
unknown. It is postulated that children with JHTS are more susceptible for
cortical spreading depression, as it is a proposed underlying mechanism for
migraine. Infra slow activity (ISA)describes brain activity that occurs in
frequencies below 0,1Hz21 and may be viewed as part of the natural spectrum of
rhythmic changes in neuronal network excitability, and is associated with
migraine. Infra slow activity from CSD in patients with migraine is recorded by
magnetoencephalography14. Non- invasive detection of infra slow activity of CSD
at patients with a migraine attack by more convenient EEG will be the next
step.
Study objective
Primary Objective: To measure cortical spreading depression with full-band EEG
during the migraine attack at patients aged 4 years or older. Secondary
Objective(s):
-To explore (additional) signal analysis techniques for detecting CSDs or infra
slow activity.
-To generate hypotheses about the pathophysiology of JHTS.
Study design
This is an explorative prospective observational case-control pilot.
Study burden and risks
EEG is a routine, everyday investigation. Serious or major adverse events are
not expected and the risk of an increase of morbidity or mortality is
negligible. Potential detrimental effects are discomfort and local skin defects
caused by the EEG electrodes. In case of important skin defects, electrodes
will be removed. When EEG is frightening for the subjects, and create
discomfort, electrodes will be removed.
When unexpected results occur, indicating an unexpected disorder, a neurologist
will be asked in consult. He will consider if this discovery has consequences
for the patient. If it is, the treating doctor, parent/legal representative and
patient will be informed.
The context in which this study is set up is the juvenile head trauma syndrome.
As described in the introduction, van der Veek et al postulated that children
with JHTS are more susceptible for cortical spreading depression, as it is a
proposed underlying mechanism for migraine. Children have a different
manifestation of migraine attacks compared to adults. The duration of a
migraine attack can be shorter in children, with a minimum duration of one
hour. Localization of the headache can be bilateral, compared to the unilateral
localization in adults. There*s more variability in associated symptoms;
difficulty in thinking, light headedness and fatigue can be presented.
EEG at children could show different results compared to EEG at adults. As
described in the introduction, Bowyer et al has recorded infra slow activity
from CSD in adult patients with migraine by MEG14. It is not yet know if infra
slow activity from CSD is recordable in children to.
Haaksbergerstraat 55
Enschede 7500 KA
NL
Haaksbergerstraat 55
Enschede 7500 KA
NL
Listed location countries
Age
Inclusion criteria
-Age 4 years and older.
-Diagnosis of acute migraine attack with or without aura
-Visiting the headache outpatient service
Exclusion criteria
Known comorbidity, that could interfere with the EEG outcome
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL55348.044.15 |
OMON | NL-OMON26573 |