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Completed

NCT Number: NCT02328976

Hypothalamus Connectivity in Chronic and Episodic Migraine

The purpose is to compare, using functional magnetic resonance imagery in resting-state, the connectivity of the hypothalamus in 2 groups of migraineurs. The first group is composed of chronic migraineurs, studied outside a migraine attack and is compared to gender- and age- matched episodic migraineurs with very few attacks per month and studied in the attack-free period. The primary outcome will be the connectivity index of the hypothalamus to brainstem areas activated during migraine attacks and to the trigeminal-cervical complex.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital

Toulouse, 31052, France

About this study

Functional magnetic resonance imagery allows identification of correlations during rest between remote brain areas (functional connectivity) through their highly correlated low-frequency spontaneous fluctuations. This technique is interesting because it is atraumatic, takes place in resting condition, without administration of substances. Only one study of connectivity with functional magnetic resonance imagery in resting state, in headache-free period of migraine, has shown differences in the connection of the periaqueductal gray matter to the pain matrix in migraineurs and controls. Our region of interest is the hypothalamus because our group demonstrated activation in this area during migraine attacks and we hypothesised that the hypothalamus could trigger migraine attacks. We want to compare 2 groups of migraineurs. The first group is composed of chronic migraineurs with >15 days with headache per month, compared to the 2nd group composed of age- and gender-matched episodic migraineurs with < 4 days of migraine per month, without prophylactic treatment. Our purpose is to study the connectivity of the hypothalamus to midbrain and pons areas activated in previous studies using positon emission tomography (PET) in spontaneous migraine attacks. The connectivity of the hypothalamus with the trigeminal-cervical complex, conveying the pain from cranial vasculature and dura-mater playing a major role in migraine attack, has never been studied before, mainly for anatomical reasons. Our secondary purpose is to study the connectivity of the hypothalamus with the pain matrix and the possible correlations with depression, allodynia and attack treatment overuse.

The primary outcome is the connectivity index of the hypothalamus to the midbrain and pons area known to be activated in migraine attacks and the trigeminal-cervical complex The secondary outcome is the connectivity index of the hypothalamus with the pain matrix (thalamus, sensitive-motor cortex, cingular cortex) This study is a comparative monocentric pathophysiological study of patients with migraine.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients fulfilling international criteria of chronic migraine (with or without medication overuse)
  • age 18-65 years,
  • with or without migraine prophylactic treatment (unchanged for 3 months). Inclusion criteria of patients with episodic migraine are: age- and- gender matched patients, fulfilling international criteria: migraine without aura, with 4 days with migraine/month, without prophylactic treatment, without history of chronic migraine

Exclusion criteria

  • evolutive severe coexistent chronic disease,
  • MRI contra-indications

Treatment and study plan

Functional magnetic resonance imaging (fMRI)

Other

both chronic and episodic patients with migraine have a specific functional Magnetic Resonance Imaging (fMRI)

Primary outcomes

  1. connectivity index measure

    Time frame: 3 months

    connectivity between hypothalamus and nociception areas

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

Hypothalamus Connectivity in Chronic and Episodic Migraine in Headache-free Period: A Resting State Functional Magnetic Resonance Imaging Study

Acronym: HYPOTHAMIG

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Dec 31, 2014
Registry last updated
Nov 10, 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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