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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
Leiden University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Migraine Disorders

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts 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)

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

    First Posted
    December 30, 2019
    Last Updated
    January 5, 2020
    Sponsor
    Leiden University Medical Center
    Collaborators
    Netherlands Organisation for Scientific Research, European Commission
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    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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