Hypothalamus Connectivity in Chronic and Episodic Migraine
HYPOTHAMIG
1 other identifier
interventional
53
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2014
CompletedStudy Start
First participant enrolled
May 1, 2014
CompletedFirst Posted
Study publicly available on registry
December 31, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedNovember 10, 2020
November 1, 2020
1.7 years
February 25, 2014
November 9, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
connectivity index measure
connectivity between hypothalamus and nociception areas
3 months
Study Arms (2)
chronic migraineurs
EXPERIMENTALfunctional Magnetic Resonance Imaging (fMRI) analysis to compare connectivity of hypothalamus
Episodic migraineurs
EXPERIMENTALfunctional Magnetic Resonance Imaging (fMRI) analysis to compare connectivity of hypothalamus
Interventions
both chronic and episodic patients with migraine have a specific functional Magnetic Resonance Imaging (fMRI)
Eligibility Criteria
You may qualify if:
- patients fulfilling international criteria of chronic migraine (with or without medication overuse)
- age 18-65 years,
You may not qualify if:
- evolutive severe coexistent chronic disease,
- MRI contra-indications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital
Toulouse, 31052, France
Related Publications (2)
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.
PMID: 23602115BACKGROUNDLerebours 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.
PMID: 30836766RESULT
Study Officials
- PRINCIPAL INVESTIGATOR
Nelly FABRE, MD
University Hospital, Toulouse
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2014
First Posted
December 31, 2014
Study Start
May 1, 2014
Primary Completion
January 1, 2016
Study Completion
February 1, 2017
Last Updated
November 10, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share