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MRI to Assess the Effects of Dysautonomia and Chronic Nausea on Brain Transmitters

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2013 by Wake Forest University Health Sciences.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
John Fortunato, Wake Forest University Baptist Medical Center Identifier:
First received: September 11, 2012
Last updated: March 28, 2013
Last verified: March 2013
The purpose of this research study is to better understand what causes dysautonomia and how this affects blood pressure and pulse. Dysautonomia is a condition of the autonomic nervous system. It is associated with fluctuations in blood pressure and pulse and may cause symptoms of nausea and belly pain, fatigue, excessive thirst, lightheadedness, dizziness, feelings of anxiety or panic, and fainting. A common example of dysautonomia is postural orthostatic tachycardia syndrome or POTS. Sometimes symptoms worsen when people move from lying down to standing, called orthostatic intolerance. We would like to learn more about the link between orthostatic intolerance and nausea. While medications currently used to treat orthostatic intolerance and nausea have proven to be effective in some patients, this may not be the best treatment for everyone as long term use could pose certain risks including high blood pressure. In order to provide a more focused and safer treatment for patients suffering from nausea and orthostatic intolerance, we have looked at how the blood pressure, pulse, and certain blood tests change during a tilt table test. This test helps to create the same circumstances that patients with orthostatic intolerance experience when they stand. To better understand if some of these problems are associated with the brain, we will study MRI in patients with dysautonomia compared to children without dysautonomia. This information may allow us to use alternative and safer treatments in the future.


Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Study Title: Brain Transmitters/Metabolites, Magnetic Resonance Spectroscopy, and Brain Connectivity: Diagnostic Strategies to Study the Effects of Non-Pharmacologic Therapies for Dysautonomia and Chronic Nausea

Resource links provided by NLM:

Further study details as provided by Wake Forest University Health Sciences:

Primary Outcome Measures:
  • Assessment of the implication of dysautonomia on the brain and better evaluate its potential mechanistic process. [ Time Frame: Assessments will occur in a one and a half hour visit. ]
    The first objective of the proposed project is to study central transmitter/metabolite profiles using in vivo 1H Magnetic Resonance Spectroscopy (MRS) in children with dysautonomia diagnosed by tilt table testing compared to healthy children without symptoms of dysautonomia. The second objective will be to determine whether dysautonomia associated with nausea and cardiovascular instability shares common alterations in brain networks. We will be using cognitive and sensory processing tasks based on our prior experience with both traditional fMRI and network analyses.

Estimated Enrollment: 18
Study Start Date: August 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Healthy subjects without symptoms of dysautonomia.
Neurocardiogenic syncope
Fainting due to sudden drop in blood pressure.
Orthostatic hypotension
Sudden decrease in blood pressure while standing.
Postural Orthostatic Tachycardic Syndrome
Increased heart rate when standing.


Ages Eligible for Study:   9 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
A combination of male and female subjects who are healthy or ahve dysautonomia/

Inclusion Criteria:

  • subjects who have completed tilt autonomic testing
  • subjects from 9 - 18 years of age

Exclusion Criteria:

  • subjects who have a metabolic, mechanical, or mucosal inflammatory cause which has been defined to explain their gastrointestinal symptoms
  • Patients with cardiac or cardiovascular disease, malignancy, psychiatric illness, neurodevelopmental delay, or other co-morbid conditions
  • Patients with with pacemakers, implanted devices, or any other MRI contraindications will be excluded from this study.
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Please refer to this study by its identifier: NCT01692561

Contact: John Fortunato, MD (336) 716-3009
Contact: Anya Brown (336) 716-4325

United States, North Carolina
Wake Forest University Baptist Medical Center Recruiting
Winston Salem, North Carolina, United States, 27157
Contact: John Fortunato, MC    336-716-3009   
Principal Investigator: John Fortunato, MD         
Sponsors and Collaborators
Wake Forest University Health Sciences
Principal Investigator: John Fortunato, M.D. Wake Forest University Health Sciences
  More Information

Responsible Party: John Fortunato, Associate Professor, Wake Forest University Baptist Medical Center Identifier: NCT01692561     History of Changes
Other Study ID Numbers: WFMCMRI 001
JEF MRI 001 ( Other Grant/Funding Number: The Center for Biomolecular Imaging )
Study First Received: September 11, 2012
Last Updated: March 28, 2013

Keywords provided by Wake Forest University Health Sciences:
Postural orthostatic tachycardic hypotension
Neurocardiogenic vasovagal syncope

Additional relevant MeSH terms:
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases processed this record on March 23, 2017