Brain Diseases, Central Nervous System Diseases, Headache Disorders, Headache Disorders, Primary, Migraine Disorders, Migraine Without Aura, Nervous System Diseases
Conditions
Brief summary
To investigate the glutaminergic system in the onset of migraine-like attacks.
Detailed description
Glyceryl trinitrate infusion (GTN) is used to provoke migraine-like attacks in female migraine without aura patients. Apart from migraine without aura patients healthy female controls are also included as a control group. Over the course of a single day these females (migraineurs and healthy controls) were scanned three times on fixed time slots: before GTN infusion (baseline), 90 minutes and 270 minutes after start of GTN infusion. Scans are acquired on a 7 tesla scanner (Philips, Cleveland, USA) on software release 3 using a 32 channel receive array using single-volume proton magnetic resonance spectroscopy (1H MRS) with a volume of interest in the visual cortex glutamate, in which glutamate, GABA and other metabolites will be assessed. The primary endpoint; glutamate level changes towards the pre-ictal and ictal state with other metabolite (e.g. glutamine and GABA) changes as secondary endpoints.
Interventions
DRUGGlyceryl trinitrate (I.V. infusion 0.5 µg/kg/min over 20 min)
Sponsors
Netherlands Organisation for Scientific Research
European Commission
Leiden University Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Diagnosed with migraine without aura according to the International Classification of Headache Disorders (ICHD)-3 beta criteria from 2013. * At least one migraine attack per month in the preceding six months
Exclusion criteria
* Other neurological disorders apart from migraine * Chronic medication apart from oral contraceptives * Migraine with aura * Chronic migraine with 15 or more headache days per month/with 8 or more migraine days per month * Medication-overuse headache (ICHD-3 beta criteria) * Women who are breastfeeding, pregnant, or planning to become pregnant * Contra-indications for 7 tesla MRI scanner * Contra-indications for GTN administration (e.g. nitrate allergy, heart condition) * Healthy controls (with no first degree relative with migraine or trigeminal autonomic cephalalgia)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glutamate | From baseline towards the pre-ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) and ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) state | Changes in glutamate level |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| GABA | From baseline towards the pre-ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) and ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) state | Changes in GABA level |
| N-acetylaspartate | From baseline towards the pre-ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) and ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) state | Changes in N-acetylaspartate level |
| Phosphoethanolamine | From baseline towards the pre-ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) and ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) state | Changes in phosphoethanolamine level |
| Myo-inositol | From baseline towards the pre-ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) and ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) state | Changes in myo-inositol level |
| Glutamine | From baseline towards the pre-ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) and ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) state | Changes in glutamine level |
| Aspartate | From baseline towards the pre-ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) and ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) state | Changes in aspartate level |
| Creatine | From baseline towards the pre-ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) and ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) state | Changes in creatine level |
| Choline | From baseline towards the pre-ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) and ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) state | Changes in choline level |
| Glutathione | From baseline towards the pre-ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) and ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) state | Changes in glutathione level |
Outcome results
None listed