To capture changes in cortical excitability, by using VEP-EEG recordings at home, in the pre-ictal phase of a migraine attack to serve as an early marker for upcoming attacks.
ID
Source
Brief title
Condition
- Headaches
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the EEG harmonic response power to visual chirp
stimulation in a frequency band of 22-32 Hz during the pre-ictal phase,
compared to the interictal phase.
Secondary outcome
The secondary study parameters are:
- EEG driving, harmonic and overall response power to visual chirp stimulation
in
o Low frequency band: 10-18 Hz
o Medium frequency band: 19-26 Hz
o High frequency band: 27-40 Hz
o Overlapping frequency band: 22-32 Hz (only for driving and overall response)
during the pre-ictal phase, compared to the interictal phase.
- EEG response power at driving, harmonic and intermodulation frequencies in
response to visual multisine stimulation.
- EEG resting state power in the traditional delta (0.5-4 Hz), theta (4-8 Hz),
alpha (8-12 Hz), beta (12-30 Hz) and gamma (30-80 Hz) ranges during the
pre-ictal phase, compared to the interictal phase.
Background summary
Migraine attacks are highly unpredictable, thereby having a major impact on the
daily life of migraine patients - causing increased anxiety, depression, and
feelings of loss of control. Unfortunately, the unpredictability of a migraine
attack also complicates studying attack-related neurobehavioral and
neurophysiological changes. Hence, traditional headache diaries provide
insight into attack patterns and provoking trigger mechanisms but lacks
continuous information on what happens in the brain or the opportunity for
detecting minimal behavioural alterations preceding an attack.
In previous work by our group we have developed a longitudinal protocol for the
registration of brain activity by encephalographic (EEG) recordings in the
hospital setting. We often found patients experienced no attacks or delayed
attacks, possibly due to feelings of stress arising from hospital visits which
might have suppressed an impending migraine attack. However, patients that did
experience an attack in the hospital setting presented EEG changes prior to the
ictal phase that may have potential to serve as an early warning sign for
upcoming attacks in the future (Perenboom et al. 2020)1. As a next step, we
wish to further strengthen these findings by bringing our recording protocol to
the home environment of the patient. Repetitive EEG recordings at patient*s
homes are urgently needed to help identify early warning signs of upcoming
migraine attacks.
Study objective
To capture changes in cortical excitability, by using VEP-EEG recordings at
home, in the pre-ictal phase of a migraine attack to serve as an early marker
for upcoming attacks.
Study design
A longitudinal, non-interventional study of VEP-EEG measurements at patients
homes.
Study burden and risks
The risk of complications is negligible. Participants might perceive the
repeated home measurements as impractical, however, our experience with other
repeated measurement studies in migraine patients shows the feasibility of such
a study. In addition, patients will fill out a daily e-diary.
Albinusdreef 2
Leiden 2333ZA
NL
Albinusdreef 2
Leiden 2333ZA
NL
Listed location countries
Age
Inclusion criteria
- >=18 years of age
- Fulfil ICHD-3 criteria for episodic migraine
- Must experience active migraine; which is defined for this study as at least
1 attack per month, but preferably at least 2
Exclusion criteria
- Unable or unwilling to use the headache E-dairy on a daily basis;
- Diagnosed with other (chronic) neurological diseases such as Parkinson*s
disease, epilepsy etc. that may interfere with the results of this study;
- Chronic migraine as defined by the ICHD-3;
- Severe depression and/or panic disorders and/or schizophrenia and/or
psychiatric disorders;
- Inability to differentiate between migraine and other headaches;
- Comorbidity with Cluster Headache or other TACs.
- Insufficient proficiency in the Dutch language to complete the headache
e-diary.
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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In other registers
| Register | ID |
|---|---|
| CCMO | NL85619.058.24 |