MRI to Assess the Effects of Dysautonomia and Chronic Nausea on Brain Transmitters
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 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|
- 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. ] [ Designated as safety issue: No ]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.
|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.
Fainting due to sudden drop in blood pressure.
Sudden decrease in blood pressure while standing.
Postural Orthostatic Tachycardic Syndrome
Increased heart rate when standing.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01692561
|Contact: John Fortunato, MD||(336) firstname.lastname@example.org|
|Contact: Anya Brown||(336) email@example.com|
|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 firstname.lastname@example.org|
|Principal Investigator: John Fortunato, MD|
|Principal Investigator:||John Fortunato, M.D.||Wake Forest Baptist Health|