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fMRI in Blood Phobia Syncope

This study has been withdrawn prior to enrollment.
(Could not get funding for fMRI studies at this time.)
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Satish R. Raj, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00715065
First received: July 10, 2008
Last updated: January 7, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention
Syncope
Blood Injury Phobia
Autonomic Dysfunction
 Procedure: fMRI Scan

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Neuroimaging in Blood Phobia Syncope

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • fMRI BOLD signal [ Time Frame: Immediate ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood Injection Symptoms Scale [ Time Frame: Single visit ] [ Designated as safety issue: No ]
  • Disgust Scale (Revised) [ Time Frame: Single Visit ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: June 2010
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Satish R. Raj, Assistant Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00715065     History of Changes
Other Study ID Numbers: 080608, NIH UL1 RR024975
Study First Received: July 10, 2008
Last Updated: January 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
syncope
faint
blood
blood injury phobia
phobia

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

ClinicalTrials.gov processed this record on May 16, 2013