NCT Number: NCT04220606
1H Magnetic Resonance Spectroscopy in Migraine Patients
To investigate the glutaminergic system in the onset of migraine-like attacks.
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Notify MeKey information
Conditions
Age range
18 year–50 year
Sex eligibility
Female
Study type
Interventional
Phase
Not applicable
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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)
Treatment and study plan
Primary outcomes
-
Glutamate
Time frame: 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 outcomes
-
Glutamine
Time frame: 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
-
GABA
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
-
Glutathione
Time frame: 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
-
Aspartate
Time frame: 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
Time frame: 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
Time frame: 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
Sponsors and collaborators
Lead sponsor
Leiden University Medical Center
Other
Collaborators
- European Commission
- Netherlands Organisation for Scientific Research
Registry information
Official study title
Glutamate Concentrations in the Brain Over the Course of a Migraine-like Attack
Important dates
- Study start
- 2015
- Primary completion
- 2016
- Study completion
- 2016
- First posted
- Jan 7, 2020
- Registry last updated
- Jan 7, 2020
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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