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Hypothalamus Connectivity in Chronic and Episodic Migraine (HYPOTHAMIG)

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ClinicalTrials.gov Identifier: NCT02328976
Recruitment Status : Completed
First Posted : December 31, 2014
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Migraine Other: functional Magnetic Resonance Imaging (fMRI) Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Hypothalamus Connectivity in Chronic and Episodic Migraine in Headache-free Period: A Resting State Functional Magnetic Resonance Imaging Study
Study Start Date : May 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine

Arm Intervention/treatment
Experimental: chronic migraineurs
functional Magnetic Resonance Imaging (fMRI) analysis to compare connectivity of hypothalamus
Other: functional Magnetic Resonance Imaging (fMRI)
both chronic and episodic patients with migraine have a specific functional Magnetic Resonance Imaging (fMRI)

Experimental: Episodic migraineurs
functional Magnetic Resonance Imaging (fMRI) analysis to compare connectivity of hypothalamus
Other: functional Magnetic Resonance Imaging (fMRI)
both chronic and episodic patients with migraine have a specific functional Magnetic Resonance Imaging (fMRI)




Primary Outcome Measures :
  1. connectivity index measure [ Time Frame: 3 months ]
    connectivity between hypothalamus and nociception areas



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02328976


Locations
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France
University Hospital
Toulouse, France, 31052
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Nelly FABRE, MD University Hospital, Toulouse
Publications:
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02328976    
Other Study ID Numbers: 13 197 02
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases