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Hypothalamus Connectivity in Chronic and Episodic Migraine

NCT ID: NCT02328976

Last Updated: 2020-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2017-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Migraine

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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chronic migraineurs

functional Magnetic Resonance Imaging (fMRI) analysis to compare connectivity of hypothalamus

Group Type EXPERIMENTAL

functional Magnetic Resonance Imaging (fMRI)

Intervention Type OTHER

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

Episodic migraineurs

functional Magnetic Resonance Imaging (fMRI) analysis to compare connectivity of hypothalamus

Group Type EXPERIMENTAL

functional Magnetic Resonance Imaging (fMRI)

Intervention Type OTHER

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

Interventions

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functional Magnetic Resonance Imaging (fMRI)

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* patients fulfilling international criteria of chronic migraine (with or without medication overuse)
* age 18-65 years,

Exclusion Criteria

* evolutive severe coexistent chronic disease,
* MRI contra-indications
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nelly FABRE, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

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University Hospital

Toulouse, , France

Site Status

Countries

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France

References

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Denuelle M, Fabre N. Functional neuroimaging of migraine. Rev Neurol (Paris). 2013 May;169(5):380-9. doi: 10.1016/j.neurol.2013.02.002. Epub 2013 Apr 18.

Reference Type BACKGROUND
PMID: 23602115 (View on PubMed)

Lerebours F, Boulanouar K, Barege M, Denuelle M, Bonneville F, Payoux P, Larrue V, Fabre N. Functional connectivity of hypothalamus in chronic migraine with medication overuse. Cephalalgia. 2019 Jun;39(7):892-899. doi: 10.1177/0333102419833087. Epub 2019 Mar 5.

Reference Type RESULT
PMID: 30836766 (View on PubMed)

Other Identifiers

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13 197 02

Identifier Type: -

Identifier Source: org_study_id