fMRI in Blood Phobia Syncope | NCT00715065

Studies
fMRI in Blood Phobia Syncope

NCT00715065

Sponsor

Vanderbilt University

Status

Withdrawn

Last Update Posted

Jan 9, 2013Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Syncope
Blood Injury Phobia
Autonomic Dysfunction

Interventions

fMRI Scan

Countries

United States

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

ID	Type	Description	Link
NIH UL1 RR024975

Status Module

Record Verification Date

Jan 2013

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Could not get funding for fMRI studies at this time.

Expanded Access Info

Start Date

Jun 2010

Primary Completion Date

Jun 2010Estimated

Completion Date

Jun 2010Estimated

First Submitted Date

Jul 10, 2008

First Submission Date that Met QC Criteria

Jul 14, 2008

First Posted Date

Jul 15, 2008Estimated

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

Jan 7, 2013

Last Update Posted Date

Jan 9, 2013Estimated

Name	Class
National Institutes of Health (NIH)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

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

We plan to study patient who faint in response to the sight of blood and compare them to healthy subjects who do not. We are going to use a special type of MRI scan (functional MRI) to determine if there are differences in brain activation in response to seeing bloody or gory pictures that occur before the fainting occurs.

Detailed Description

Another aim of the study is to determine whether or not differences in personality traits among people with blood phobia is associated with differences in BOLD signal responses during fMRI.

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

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
2		Healthy control subjects (who do not faint at the sight of blood)	Procedure: fMRI Scan
1		People who faint at sight of blood	Procedure: fMRI Scan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
fMRI Scan	Procedure	Subjects will undergo a functional MRI scan of the head lasting ~45 minutes. They will be repeatedly shown video clips of blood, other disgusting things, or are neutral.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
fMRI BOLD signal		Immediate

Secondary Outcomes

Measure	Description	Time Frame
Blood Injection Symptoms Scale		Single visit
Disgust Scale (Revised)		Single Visit

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18-30 years of age
1. History of at least one syncopal episode upon exposure to viewing blood (Case Group)
Negative urine pregnancy test on study day

Exclusion Criteria:

Vasoactive medications (within 2 weeks of study day)
antihypertensives
beta blockers
vasoconstrictors
Psychotropic medications (within 4 weeks of study day)
History of psychostimulant or opiate use
History of alcohol, benzodiazepine or cannabis abuse or dependence

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

30 Years

Standard Ages

Adult

Study Population

Patients with at least 1 prior syncopal episode in response to viewing blood
Healthy subjects without a history of syncope

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Satish R Raj, MD MSCI	Vanderbilt University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vanderbilt University Autonomic Dysfunction Center		Nashville	Tennessee	37232-2195	United States

Condition Browse Module

MeSH Terms

ID	Term
D013575	Syncope
D054969	Primary Dysautonomias
D010698	Phobic Disorders

Ancestor Terms

ID	Term
D014474	Unconsciousness
D003244	Consciousness Disorders
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided