1H Magnetic Resonance Spectroscopy in Migraine Patients

Migraine Disorders Clinical Trial

Official title:

Glutamate Concentrations in the Brain Over the Course of a Migraine-like Attack

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04220606
• Other study ID #: P07079.6
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: April 2016

Study information

• Verified date: January 2020
• Source: Leiden University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Leiden University Medical Center	European Commission, Netherlands Organisation for Scientific Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glutamate	Changes in glutamate level	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
Secondary	Glutamine	Changes in glutamine level	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
Secondary	GABA	Changes in GABA level	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
Secondary	N-acetylaspartate	Changes in N-acetylaspartate level	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
Secondary	Phosphoethanolamine	Changes in phosphoethanolamine level	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
Secondary	Myo-inositol	Changes in myo-inositol level	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
Secondary	Glutathione	Changes in glutathione level	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
Secondary	Aspartate	Changes in aspartate level	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
Secondary	Creatine	Changes in creatine level	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
Secondary	Choline	Changes in choline level	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