fMRI in Blood Phobia Syncope

Syncope Clinical Trial

Official title:

Neuroimaging in Blood Phobia Syncope

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00715065
• Other study ID #: 080608
• Secondary ID: NIH UL1 RR024975
• Status: Withdrawn
• Phase: N/A
• First received: July 10, 2008
• Last updated: January 7, 2013
• Start date: June 2010
• Est. completion date: June 2010

Study information

• Verified date: January 2013
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 30 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Autonomic Dysfunction
• Autonomic Nervous System Diseases
• Blood Injury Phobia
• Phobic Disorders
• Primary Dysautonomias
• Syncope

Intervention

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.

Locations

Country	Name	City	State
United States	Vanderbilt University Autonomic Dysfunction Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fMRI BOLD signal		Immediate	No
Secondary	Blood Injection Symptoms Scale		Single visit	No
Secondary	Disgust Scale (Revised)		Single Visit	No