Investigation of the Blood-brain and Blood-dura Barrier D... | NCT02202486

Studies
Investigation of the Blood-brain and Blood-dura Barrier Durin Migraine Attacks Using MRI

NCT02202486

Sponsor

Glostrup University Hospital, Copenhagen

Status

Unknown status

Last Update Posted

Jul 29, 2014Estimated

Enrollment

600Estimated

Phase

Not provided

Conditions

Migraine With Aura
Migraine Without Aura
Chronic Migraine

Interventions

Brain MRI

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2012

Primary Completion Date

Jul 2015Estimated

Completion Date

Dec 2015Estimated

First Submitted Date

Jul 17, 2014

First Submission Date that Met QC Criteria

Jul 25, 2014

First Posted Date

Jul 29, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 25, 2014

Last Update Posted Date

Jul 29, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Faisal Mohammad Amin, medical doctor, Glostrup University Hospital, CopenhagenPrincipal Investigator

Lead Sponsor

Glostrup University Hospital, CopenhagenOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Brain MRI during and outside migraine attacks.

Up to 600 patients will be recruited, who will be given a phone number that they can call when they get migraine attacks.

The study will continue until 20 patients with migraine with aura, 20 patients without aura, 20 patients with chronic migraine have completed the study.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

600Estimated

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
Migraine with aura	Brain MRI	Other: Brain MRI
Migraine without aura	Brain MRI	Other: Brain MRI
Chronic migraine	Brain MRI	Other: Brain MRI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Brain MRI	Other	Brain MRI with gadolinium contrast	Chronic migraine Migraine with aura Migraine without aura

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Migraine patients.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Faisal M Amin, MD	Contact	+4538633066		faisal.mohammad.amin.01@regionh.dk

Overall Officials

Name	Affiliation	Role
Faisal M Amin, MD	Danish Headache Center, Glostrup Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Danish Headache Center, Glostrup Hospital	Recruiting	Glostrup Municipality	Copenhagen	2600	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34418951	Derived	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.

ID	Term
D020325	Migraine with Aura
D020326	Migraine without Aura

ID	Term
D008881	Migraine Disorders
D051270	Headache Disorders, Primary
D020773	Headache Disorders
D001927	Brain Diseases