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

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ClinicalTrials.gov Identifier: NCT01692561
Recruitment Status : Active, not recruiting
First Posted : September 25, 2012
Last Update Posted : April 20, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease
Dysautonomia

Study Design

Study Type : Observational
Estimated Enrollment : 18 participants
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
Study Start Date : August 2012
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
normaL
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.


Outcome Measures

Primary Outcome Measures :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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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/
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01692561


Locations
United States, North Carolina
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
Principal Investigator: Debra Diz, M.D. Wake Forest University Health Sciences
More Information

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT01692561     History of Changes
Other Study ID Numbers: WFMCMRI 001
JEF MRI 001 ( Other Grant/Funding Number: The Center for Biomolecular Imaging )
First Posted: September 25, 2012    Key Record Dates
Last Update Posted: April 20, 2017
Last Verified: April 2017

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

Additional relevant MeSH terms:
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases