fMRI in Blood Phobia Syncope

NCT00715065 | Withdrawn

• 2 other identifiers: 080608NIH UL1 RR024975
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Syncope; Blood Injury Phobia; Autonomic Dysfunction

Keywords

syncope; faint; blood; blood injury phobia; phobia

Outcome Measures

Primary Outcomes (1)

• fMRI BOLD signal

  Immediate

Secondary Outcomes (2)

• Blood Injection Symptoms Scale

  Single visit

• Disgust Scale (Revised)

  Single Visit

Study Arms (2)

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

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.

1; 2

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Vanderbilt University Autonomic Dysfunction Center

Nashville, Tennessee, 37232-2195, United States

Location

MeSH Terms

Conditions

Syncope; Primary Dysautonomias; Phobic Disorders

Condition Hierarchy (Ancestors)

Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Autonomic Nervous System Diseases; Anxiety Disorders; Mental Disorders

Study Officials

• Satish R Raj, MD MSCI

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 10, 2008
• First Posted: July 15, 2008
• Study Start: June 1, 2010
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: January 9, 2013

Record last verified: 2013-01

Locations

US (1)