fMRI in Blood Phobia Syncope

January 7, 2013 updated by: Satish R. Raj, Vanderbilt University

Neuroimaging in Blood Phobia Syncope

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.

Study Overview

Status

Withdrawn

Intervention / Treatment

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 Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Tennessee
      • Nashville, Tennessee, United States, 37232-2195
        • Vanderbilt University Autonomic Dysfunction Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
2
Healthy control subjects (who do not faint at the sight of blood)
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
fMRI BOLD signal
Time Frame: Immediate
Immediate

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Anticipated)

June 1, 2010

Study Completion (Anticipated)

June 1, 2010

Study Registration Dates

First Submitted

July 10, 2008

First Submitted That Met QC Criteria

July 14, 2008

First Posted (Estimate)

July 15, 2008

Study Record Updates

Last Update Posted (Estimate)

January 9, 2013

Last Update Submitted That Met QC Criteria

January 7, 2013

Last Verified

January 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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