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

This study is currently recruiting participants.
Verified March 2013 by Wake Forest Baptist Health
Sponsor:
Information provided by (Responsible Party):
John Fortunato, Wake Forest University Baptist Medical Center
ClinicalTrials.gov Identifier:
NCT01692561
First received: September 11, 2012
Last updated: March 28, 2013
Last verified: March 2013
  Purpose

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
Dysautonomia

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 Baptist Health:

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. ] [ 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.


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)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   9 Years to 18 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01692561

Contacts
Contact: John Fortunato, MD (336) 716-3009 jfortuna@wakehealth.edu
Contact: Anya Brown (336) 716-4325 anybrown@wakehealth.edu

Locations
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    jfortuna@wakehealth.edu   
Principal Investigator: John Fortunato, MD         
Sponsors and Collaborators
Wake Forest Baptist Health
Investigators
Principal Investigator: John Fortunato, M.D. Wake Forest Baptist Health
  More Information

No publications provided

Responsible Party: John Fortunato, Associate Professor, Wake Forest University Baptist Medical Center
ClinicalTrials.gov Identifier: NCT01692561     History of Changes
Other Study ID Numbers: WFMCMRI 001, JEF MRI 001
Study First Received: September 11, 2012
Last Updated: March 28, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on April 17, 2014