NCT02202486

Brief Summary

Substudy 1 Blood-brain barrier breakdown has been proposed in migraine patients. Our hypothesis that we will test in this study is that the blood-brain barrier breaks down during migraine attacks but not out side attacks using MRI. Substudy 2 Altered cerebral resting-state functional connectivity networks have been reported in migraine patients outside migraine attacks. What happens during migraine attacks has never been investigated. The hypothesis we will test is that pain related networks are affected during spontaneous attacks using functional MRI. Substudy 3 Old studies report that cerebral blood flow (CBF) is altered in patients with migraine with aura, but not in those without aura. We hypothesize that CBF is altered regionally during attacks, which we will investigate in this study using arterial spin labeling (ASL). Substudy 4 Structural changes using voxel-based morphometry (VBM) of the brain have been suggested but never investigated during migraine attacks. Our hypothesis is that pain related structures show altered VBM during spontaneous migraine attacks.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 29, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

July 29, 2014

Status Verified

July 1, 2014

Enrollment Period

2.8 years

First QC Date

July 17, 2014

Last Update Submit

July 25, 2014

Conditions

Migraine With AuraMigraine Without AuraChronic Migraine

Outcome Measures

Primary Outcomes (4)

  • Blood-brain barrier alteration during migraine attacks

    Up to 1 year

  • Cerebral blood flow alteration during migraine attacks

    Up to 1 year

  • Resting-state functional brain connectivity alteration during migraine attacks

    Up to 1 year

  • Voxel-based morphometry alteration during migraine attacks

    Up to 1 year

Study Arms (3)

Migraine with aura

Brain MRI

Other: Brain MRI

Migraine without aura

Brain MRI

Other: Brain MRI

Chronic migraine

Brain MRI

Other: Brain MRI

Interventions

Brain MRIOTHER

Brain MRI with gadolinium contrast

Chronic migraineMigraine with auraMigraine without aura

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Migraine patients.

You may qualify if:

  • diagnosis of migraine with aura, migraine without aura, or chronic migraine according to the International Headache Society.
  • written informed consent.
  • use of anticonceptive method by women in childbearing age.

You may not qualify if:

  • tension type headache more than 5/month during last year.
  • tension type headache on the experimental day.
  • use of antimigraine medication or pain-killer on the experimental day before MRI.
  • pregnant or breastfeeding women.
  • contraindications against MRI.
  • history or clinical sign of cardio- or cerebrovascular disease.
  • untreated severe mental disorder or drug abuse.
  • other diseases or disorders interpreted, by the examining doctor, to interfere with participation in the study.
  • not accepting information about potential accidental finding during experiment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Danish Headache Center, Glostrup Hospital

Glostrup Municipality, Copenhagen, 2600, Denmark

RECRUITING

Related Publications (1)

  • Amin FM, De Icco R, Al-Karagholi MA, Raghava JM, Wolfram F, Larsson HBW, Ashina M. Investigation of cortical thickness and volume during spontaneous attacks of migraine without aura: a 3-Tesla MRI study. J Headache Pain. 2021 Aug 21;22(1):98. doi: 10.1186/s10194-021-01312-9.

    PMID: 34418951DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Creatinine, blood glucose, potassium, haemoglobin, erytrocyte profile

MeSH Terms

Conditions

Migraine with AuraMigraine without Aura

Condition Hierarchy (Ancestors)

Migraine DisordersHeadache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Faisal M Amin, MD

    Danish Headache Center, Glostrup Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Faisal M Amin, MD

CONTACT

+4538633066faisal.mohammad.amin.01@regionh.dk

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical doctor

Study Record Dates

First Submitted

July 17, 2014

First Posted

July 29, 2014

Study Start

September 1, 2012

Primary Completion

July 1, 2015

Study Completion

December 1, 2015

Last Updated

July 29, 2014

Record last verified: 2014-07

Locations

DK(1)