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OpenTrials
Completed

NCT Number: NCT04220606

1H Magnetic Resonance Spectroscopy in Migraine Patients

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

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Drug

Primary outcomes

  1. Glutamate

    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

    Changes in glutamate level

Secondary outcomes

  1. Glutamine

    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

    Changes in glutamine level

  2. GABA

    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

    Changes in GABA level

  3. N-acetylaspartate

    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

    Changes in N-acetylaspartate level

  4. Phosphoethanolamine

    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

    Changes in phosphoethanolamine level

  5. Myo-inositol

    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

    Changes in myo-inositol level

  6. Glutathione

    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

    Changes in glutathione level

  7. Aspartate

    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

    Changes in aspartate level

  8. Creatine

    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

    Changes in creatine level

  9. Choline

    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

    Changes in choline level

Sponsors and collaborators

Lead sponsor

Leiden University Medical Center

Other

Collaborators

  • European Commission
  • Netherlands Organisation for Scientific Research

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 7, 2020
Registry last updated
Jan 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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