Objectives- We want to study time-dependent activation in neuronal networks related to pain, vigilance and autonomic functioning in migraine patients during different migraine phases (including premonitory phase);- We want to correlate these changes…
ID
Source
Brief title
Condition
- Headaches
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Outcome parameters:
- MR: RSN measurements: Time-dependent changes in neuronal activity as
reflected by the BOLD signal in several functional networks;
Time-dependent changes in regions; (voxel-wise) functional connectivity.
- Cognitive tests: results of global-local task
- Venapuncture: levels of female hormones (LH, FSH, oestrogen)
- Questionnaires: information on presence/ absence of premonitory symptoms and
headache
Secondary outcome
n.a.
Background summary
Background
Migraine is a common, multifactorial brain disorder characterised by chronic,
recurrent, disabling attacks of headache, autonomic features (migraine without
aura), and, in one third of patients, transient neurological aura symptoms
(migraine with aura). Although the pathophysiology of the migraine and aura are
reasonably well understood (activation of the trigeminovascular system (TGVS)
is pivotal), the triggering mechanisms for the initiation of migraine attacks
are not fully understood. Several central nervous system pathways (cortical and
subcortical) seem to be involved, including pain pathway, pathways modulating
concentration and/ or vigilance, autonomics regions, and brainstem/
hypothalamic networks.
Hypothesis
We hypothesize that migraine related brain networks show time-dependent
alterations in activity preceding the onset of a migraine brain and during the
different phases of the migraine attack.
Study objective
Objectives
- We want to study time-dependent activation in neuronal networks related to
pain, vigilance and autonomic functioning in migraine patients during different
migraine phases (including premonitory phase);
- We want to correlate these changes in neuronal activity to clinical
alterations.
Study design
Methods and Design
In this prospective study, 20 migraine patients with menstrually related
migraine and 20 matched controls (age, oral anti-conceptives; BMI; timing of
menstrual cycle) will undergo a daily 15 minute MR-session to asses
functionality of the brain at rest using fMRI (RSN), on approximately 5
consecutive days, including days preceding the migraine attack and the first
day of the attack proper. Clinical, neuropshychological and biochemical
measurements will be performed on every measurement day.
Study burden and risks
n.a.
Albinusdreef 2
2333 ZA Leiden
NL
Albinusdreef 2
2333 ZA Leiden
NL
Listed location countries
Age
Inclusion criteria
Migraineurs
Inclusion criteria; i) Female migraine patients, suffering from menstrually related migraine according to IHS criteria; ii) in total, 1-2 attacks of migraine per month; iii) aged between 18-50 years; iv) provided written informed consent; v) preferable, no use of acute anti migraine medication during the study* and vi) a regular menstrual cyclus.;Healthy controls
Inclusion criteria; i) Having a regular menstrual cycle; ii) aged between 18-50 years; iii) provided written informed consent;
Exclusion criteria
Migraineurs
Exclusion criteria: i) other neurological or psychiatric disease; ii) contraindications for being in a MR-scanner; iii) use of medications that may influence brain functioning (antidepressants; sedatives); iv) use of prophylactic antimigaine medication; v) presence of premenstrual syndrome; vi) having undergone procedures that influence regularity of menstrual cyclus, such as ovariectomy and hysterectomy; and vii) use of (oral) contraceptives.;Healthy controls
Exclusion criteria: i) any neurological or psychiatric disease, including primary headache syndrome; ii) headache prior to menstrual flow; iii) contraindications for being in a MR-scanner; iv) use of medications that may influence brain functioning (antidepressants; sedatives); v) symptoms of premenstrual syndrome; vi) having undergone procedures that influence regularity of menstrual cyclus, such as ovariectomy and hysterectomy; vii) using medication that is also prescribed for migraine prophylaxis (ß-blokkers etc.), and viii) use of (oral) contraceptives.
Design
Recruitment
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 | NL38129.058.11 |