1H Magnetic Resonance Spectroscopy in Migraine Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-04-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Migraine without aura subjects

Drug: Glyceryl trinitrate (GTN)

Group Type OTHER

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

Intervention Type DRUG

Healthy subjects

Drug: Glyceryl trinitrate (GTN)

Group Type OTHER

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

Intervention Type DRUG

Interventions

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

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes