Page 148 - Migraine, the heart and the brain

Chapter 8
month. Approval for the study was obtained from the local medical ethics committee of the Leiden University Medical Center; all participants provided informed consent.
Design
If patients agreed to participate, they were instructed to contact the study coordinator at the end of a migraine attack on the rst headache-free morning after a migraine attack. It was required that patients were headache-free, had had a good night sleep, and did not use attack medication during the last night to ensure testing was not influenced by pain, tiredness, or medication effects. Patients were then visited at home the same day to obtain the cognitive tests during the rst session. The cognitive tests were repeated 24 hours later (second session) and 12 days post attack (third session). Within each participant the second and third session were on the same hour of the day as the rst session. If a new migraine attack had occurred in between sessions 2 and 3, the third session had to be at least 3 days after the new attack. Session 3 was not allowed to take place during the prodromal phase of a following attack. To limit the time between the baseline and two post-attack sessions, a design was chosen in which the rst test session was always the rst day after the attack and, consequently, the second and third session were also in a xed order. To control for any learning effect as a result of this repeated testing, control participants without migraine history were tested with the same protocols on three sessions with the same time intervals in between. Participants were tested by four specially trained students. All participants received the same instructions. Participants were tested by the same student during all three sessions. Participants were seated in front of a laptop monitor (Dell Latitude D-600, screen size 14.1 inch, resolution 1024 x 768, luminance 99.1 cd/m2, 85 Hz) and performed all tests under the same quiet circumstances. Participants were instructed to keep caffeine or nicotine use before the second and the third session at the same level as before the rst session, so that the intra-individual consumption was likely to be constant over the three sessions. Before cognitive testing started, questionnaire data were obtained on general migraine characteristics, preceding migraine attack characteristics, general history, and medication use. Instructions for each test were according to protocol: they were read aloud by the investigator and were also shown on the computer monitor.
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