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fMRI in Blood Phobia Syncope

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00715065
Recruitment Status : Withdrawn (Could not get funding for fMRI studies at this time.)
First Posted : July 15, 2008
Last Update Posted : January 9, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Syncope Blood Injury Phobia Autonomic Dysfunction Procedure: fMRI Scan

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.

Study Design

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Neuroimaging in Blood Phobia Syncope
Study Start Date : June 2010
Estimated Primary Completion Date : June 2010
Estimated Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fainting Phobias
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
2
Healthy control subjects (who do not faint at the sight of blood)
Procedure: fMRI Scan
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.
1
People who faint at sight of blood
Procedure: fMRI Scan
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.


Outcome Measures

Primary Outcome Measures :
  1. fMRI BOLD signal [ Time Frame: Immediate ]

Secondary Outcome Measures :
  1. Blood Injection Symptoms Scale [ Time Frame: Single visit ]
  2. Disgust Scale (Revised) [ Time Frame: Single Visit ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
  1. Patients with at least 1 prior syncopal episode in response to viewing blood
  2. Healthy subjects without a history of syncope
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00715065


Locations
United States, Tennessee
Vanderbilt University Autonomic Dysfunction Center
Nashville, Tennessee, United States, 37232-2195
Sponsors and Collaborators
Vanderbilt University
National Institutes of Health (NIH)
Investigators
Principal Investigator: Satish R Raj, MD MSCI Vanderbilt University
More Information

Responsible Party: Satish R. Raj, Assistant Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00715065     History of Changes
Other Study ID Numbers: 080608
NIH UL1 RR024975
First Posted: July 15, 2008    Key Record Dates
Last Update Posted: January 9, 2013
Last Verified: January 2013

Keywords provided by Satish R. Raj, Vanderbilt University:
syncope
faint
blood
blood injury phobia
phobia

Additional relevant MeSH terms:
Syncope
Phobic Disorders
Autonomic Nervous System Diseases
Primary Dysautonomias
Anxiety Disorders
Mental Disorders
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms