Objectives- To study presence of (Cortical) Spreading Depression ((C)SD), using direct current (DC) EEG changes in migraine patients during different phases of the migraine attack;- Is there a change in DC-EEG recordings suggestive of (C)SD,…
ID
Source
Brief title
Condition
- Headaches
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Outcome measures
Large unilateral DC-potential shifts indicative of a spreading depression
during the onset and duration of a reported aura phase in MA patients, or
during the initiation of a headache phase in MO patients, comparing data from
the two hemispheres. Analyses will be adjusted for end-tidal pCO2 levels.
Secondary outcome
TMS: Motor threshold and stimulus response curves during the different phases
of migraine headache.
Background summary
Introduction
Migraine is a public health problem of great impact on both the patient and
society in western countries. Cortical Spreading Depression (CSD) is considered
to be the neurobiological substrate of migraine aura, although CSD has never
been recorded directly in migraine patients. Additionally, there is the
contested notion that CSD and possible spreading depression (SD; that may occur
outside the cortex) may also be involved in migraine attacks without a
*perceived* aura (also called clinically silent aura*). To our knowledge, no
studies into direct measurements of spreading depression in migraine using EEG
techniques have been performed. This study aims to increase our understanding
of the role of (C)SD in relation to the onset of migraine with and without
aura.
Study objective
Objectives
- To study presence of (Cortical) Spreading Depression ((C)SD), using direct
current (DC) EEG changes in migraine patients during different phases of the
migraine attack;
- Is there a change in DC-EEG recordings suggestive of (C)SD, synchronous to
migraine aura, preceding the migraine headache, in patients suffering from
migraine with aura?
- Is there a change in DC-EEG recordings, suggestive of (C)SD, preceding the
migraine headache, in patients suffering from migraine without aura?
- To study cortical excitability with TMS and EEG/EMG before and during the
initiated migraine attacks.
Study design
Methods
DC-EEG measurement will be performed in migraine patients with and without aura
during at maximum 8 hours prior to/ ending in migraine (aura). Three groups
will be included: 1) patients with migraine with aura, who are known to be
sensitive to visual triggers evoking a migraine aura and/ or attack (n=5
successfully induced auras); 2) Migraine patients in whom a migraine attack is
triggered using the GTN-model (n=15 successfully induced attacks); 3) Migraine
patients with spontaneous migraine attacks (living or working in the Leiden
region, n=5). In addition, end-tidal pCO2 will be systematically recorded using
a standard capnograph. If the condition of the subjects permits, at the
beginning of the session and before the triggered (but not spontaneous)
migraine attack starts, TMS-EEG/EMG will be done., Eventually, subject*s
conditions granted, TMS-EEG/EMG will be repeated during and after the migraine
attack.
Study burden and risks
EEG-recordings: none
GTN-infusion: light vertigo and light headache during infusion. Within 6 hours:
migraine headache will be triggered in 6/10 patients.
LED-bril offering lightflashes: no risks
Oxygenmask: no risk
TMS: can lead to slight discomfort during the evaluation, and some subjects
report local pain on the scalp that is not severe and only lasts while the
experiment lasts. In rare cases, syncope has been reported. Very rarely, a
seizure may be triggered by TMS. The risk amongst people with epilepsy is
0-3.6%.
Burden: there is no direct healthgain for participating patients. Duration of
participation (max 8 hours) is moderate duration. After careful consideration,
we think possible side effects/ risks are outweight by the expected gain in
pathophysiologic knowledge, with hopefully therapeutical consequences.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria are: i) migraine with/ without aura according to the IHS criteria; ii) baseline attack frequency of 1 to 3 attacks per month; iii) moderate or severe headache during attacks; iv) age>18 years; v) residential or working in the Heemstede region or SEIN.
Exclusion criteria
Exclusion criteria are: i) more than 10 days of headache per month; ii) inability to differentiate between migraine and other forms of headache; iii) suffering from another neurologic or psychiatric disease; iv) structural inabililty to stay supine without major movements (e.g. restless legs syndrome, tremor etc.); v) excessive sweating (may influence conduction between skin and electrodes); vii) use of neurologic or psychiatric medication that could affect cortical functioning.
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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In other registers
| Register | ID |
|---|---|
| CCMO | NL39409.058.12 |