1H Magnetic Resonance Spectroscopy in Migraine Patients
Primary Purpose
Migraine Disorders, Migraine Without Aura, Headache Disorders, Primary
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Glyceryl trinitrate (I.V. infusion 0.5 µg/kg/min over 20 min)
Sponsored by
About this trial
This is an interventional basic science trial for Migraine Disorders
Eligibility Criteria
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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Migraine without aura subjects
Healthy subjects
Arm Description
Drug: Glyceryl trinitrate (GTN)
Drug: Glyceryl trinitrate (GTN)
Outcomes
Primary Outcome Measures
Glutamate
Changes in glutamate level
Secondary Outcome Measures
Glutamine
Changes in glutamine level
GABA
Changes in GABA level
N-acetylaspartate
Changes in N-acetylaspartate level
Phosphoethanolamine
Changes in phosphoethanolamine level
Myo-inositol
Changes in myo-inositol level
Glutathione
Changes in glutathione level
Aspartate
Changes in aspartate level
Creatine
Changes in creatine level
Choline
Changes in choline level
Full Information
NCT ID
NCT04220606
First Posted
December 30, 2019
Last Updated
January 5, 2020
Sponsor
Leiden University Medical Center
Collaborators
Netherlands Organisation for Scientific Research, European Commission
1. Study Identification
Unique Protocol Identification Number
NCT04220606
Brief Title
1H Magnetic Resonance Spectroscopy in Migraine Patients
Official Title
Glutamate Concentrations in the Brain Over the Course of a Migraine-like Attack
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
April 2015 (Actual)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Leiden University Medical Center
Collaborators
Netherlands Organisation for Scientific Research, European Commission
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Disorders, Migraine Without Aura, Headache Disorders, Primary, Headache Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Migraine without aura subjects
Arm Type
Other
Arm Description
Drug: Glyceryl trinitrate (GTN)
Arm Title
Healthy subjects
Arm Type
Other
Arm Description
Drug: Glyceryl trinitrate (GTN)
Intervention Type
Drug
Intervention Name(s)
Glyceryl trinitrate (I.V. infusion 0.5 µg/kg/min over 20 min)
Primary Outcome Measure Information:
Title
Glutamate
Description
Changes in glutamate level
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
Secondary Outcome Measure Information:
Title
Glutamine
Description
Changes in glutamine level
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
Title
GABA
Description
Changes in GABA level
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
Title
N-acetylaspartate
Description
Changes in N-acetylaspartate level
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
Title
Phosphoethanolamine
Description
Changes in phosphoethanolamine level
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
Title
Myo-inositol
Description
Changes in myo-inositol level
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
Title
Glutathione
Description
Changes in glutathione level
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
Title
Aspartate
Description
Changes in aspartate level
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
Title
Creatine
Description
Changes in creatine level
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
Title
Choline
Description
Changes in choline level
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
12. IPD Sharing Statement
Plan to Share IPD
No
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1H Magnetic Resonance Spectroscopy in Migraine Patients
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