SyncopeNCT00715065
fMRI in Blood Phobia Syncope
An observational study of Syncope and Blood Injury Phobia, run by Vanderbilt University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Syncope, Blood Injury Phobia, Autonomic Dysfunction
- What is being tested?
- fMRI Scan
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Jun 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 1. Patients with at least 1 prior syncopal episode in response to viewing blood 2. Healthy subjects without a history of syncope
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Autonomic Dysfunction Center
Nashville, Tennessee, 37232-2195
About this study
Official title: 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.
Read the 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.
- Conditions
- Syncope, Blood Injury Phobia, Autonomic Dysfunction
- Being tested
- fMRI Scan
- Keywords
- syncope, faint, blood, blood injury phobia, phobia
- Medical subject headings
- Syncope, Primary Dysautonomias, Phobic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fMRI ScanProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 2 | Healthy control subjects (who do not faint at the sight of blood) Receives: Procedure: fMRI Scan | |
| 1 | People who faint at sight of blood Receives: Procedure: fMRI Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
fMRI BOLD signal
Measured: Immediate
Secondary outcomes (2)
Blood Injection Symptoms Scale
Measured: Single visit
Disgust Scale (Revised)
Measured: Single Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2008 (estimated)
- Study startJun 2010
- Primary completionJun 2010 (estimated)
- Study completionJun 2010 (estimated)
Why it stopped: Could not get funding for fMRI studies at this time.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SyncopeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Satish R. Raj, Vanderbilt University
- Investigators
- Satish R Raj, MD MSCI, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00715065
- Sponsor's protocol ID
- 080608
- Other IDs
- NIH UL1 RR024975
- Status last verified
- Jan 2013
- First submitted
- 10 Jul 2008
- Last updated
- 9 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroimaging in Blood Phobia Syncope
- ClinicalTrials.gov ID
- NCT00715065
- Acronym / sponsor ID
- 080608
- Conditions
- Syncope, Blood Injury Phobia, Autonomic Dysfunction
- Keywords
- syncope, faint, blood, blood injury phobia, phobia
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Could not get funding for fMRI studies at this time.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Jun 2010
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Jun 2010 (estimated)
- First posted
- 15 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | – | Procedure: fMRI ScanHealthy control subjects (who do not faint at the sight of blood) |
| 1 | – | Procedure: fMRI ScanPeople who faint at sight of blood |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 1. Patients with at least 1 prior syncopal episode in response to viewing blood 2. Healthy subjects without a history of syncope
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- Vasoactive medications (within 2 weeks of study day)
- antihypertensives
- beta blockers
- vasoconstrictors
- Psychotropic medications (within 4 weeks of study day)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fMRI ScanSubjects 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. | Procedure or surgery | 1, 2 |
Primary outcome
fMRI BOLD signal
Time frame: Immediate
2 secondary outcomes
Blood Injection Symptoms Scale
Time frame: Single visit
Disgust Scale (Revised)
Time frame: Single Visit
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Satish R Raj, MD MSCI principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Syncope and Blood Injury Phobia, run by Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fMRI BOLD signal (time frame: Immediate). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2013.