1H Magnetic Resonance Spectroscopy in Migraine Patients

Leiden University Medical Center (LUMC)

Status: Completed

Conditions: Headache Disorders; Migraine Disorders; Central Nervous System Diseases; Migraine Without Aura; Nervous System Diseases; Headache Disorders, Primary; Brain Diseases

Treatments: Drug: Glyceryl trinitrate (I.V. infusion 0.5 µg/kg/min over 20 min)

Study type: Interventional

Funder types: Other

Identifiers

NCT04220606

P07079.6

Details and patient eligibility

About

To investigate the glutaminergic system in the onset of migraine-like attacks.

Full 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.

Enrollment: 39 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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39 participants in 2 patient groups

Migraine without aura subjects

Other group

Description:

Drug: Glyceryl trinitrate (GTN)

Treatment:

Drug: Glyceryl trinitrate (I.V. infusion 0.5 µg/kg/min over 20 min)

Healthy subjects

Other group

Description:

Drug: Glyceryl trinitrate (GTN)

Treatment:

Drug: Glyceryl trinitrate (I.V. infusion 0.5 µg/kg/min over 20 min)