- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00715065
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Withdrawn
Conditions
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
-
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Tennessee
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Nashville, Tennessee, United States, 37232-2195
- Vanderbilt University Autonomic Dysfunction Center
-
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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
- Patients with at least 1 prior syncopal episode in response to viewing blood
- 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.
Sponsor
Collaborators
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
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 080608
- NIH UL1 RR024975
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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