MRA/fMRI Study of Spontaneous Migraine | NCT01471314

Studies
MRA/fMRI Study of Spontaneous Migraine

NCT01471314

Sponsor

Glostrup University Hospital, Copenhagen

Status

Unknown status

Last Update Posted

Aug 29, 2012Estimated

Enrollment

Not provided

Phase

Not provided

Conditions

Headache Versus Non-headache Day

Interventions

Headache day versus non-headache day

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

Aug 2012

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

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Nov 10, 2011

First Submission Date that Met QC Criteria

Nov 14, 2011

First Posted Date

Nov 15, 2011Estimated

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

Aug 28, 2012

Last Update Posted Date

Aug 29, 2012Estimated

Name	Class
Leiden University Medical Center	OTHER

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

The purpose of this study is to examine migraineurs during spontaneous migraine attacks without aura, using high resolution magnetic resonance imaging (MRI), to study following:

Changes in resting state blood-oxygenation-level-dependent-signal (BOLD-signal) using functional MRI (fMRI).
Changes in circumferences of intra- and extracranial arteries using MR-angiography (MRA).
Changes in regional and global cerebral blood flow (CBF) using the arterial spin labeling (ASL) method.

Moreover to perform diffusion tensor imaging (DTI) scans during spontaneous migraine attacks.

The migraine specific drug sumatriptan will be given to relieve pain and the effect will be registered using MRA and fMRI if possible.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Label	Type	Description	Intervention Names
Spontaneous migraine			Behavioral: Headache day versus non-headache day

Name	Type	Description	Arm Group Labels	Other Names
Headache day versus non-headache day	Behavioral		Spontaneous migraine

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Migraine without aura according to IHS criteria.

Exclusion Criteria:

Other primary headaches.
Tension-type headache more than 5 days/month.
Use of anti-pain medication before the scanning on the examination day.
Pregnant or nursing women.
Contraindication for MR scan.
Anamnestic or clinical signs of cardiovascular or cerebrovascular disease, unregulated psychiatric disease or drug misuse.
Other clinical conditions assessed by the examining doctor.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Migraine without aura

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Faisal Amin, MD, PhD student	Contact	+4538633066		famoam01@regionh.dk

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Glostrup Hospital, Faculty of Health Sciences, University of Copenhagen	Recruiting	Glostrup Municipality		DK-2600	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23578775	Derived	Amin FM, Asghar MS, Hougaard A, Hansen AE, Larsen VA, de Koning PJ, Larsson HB, Olesen J, Ashina M. Magnetic resonance angiography of intracranial and extracranial arteries in patients with spontaneous migraine without aura: a cross-sectional study. Lancet Neurol. 2013 May;12(5):454-61. doi: 10.1016/S1474-4422(13)70067-X. Epub 2013 Apr 9.