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OpenTrials
Completed

NCT Number: NCT01692561

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.

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Key information

Age range

9 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 25, 2012
Registry last updated
Apr 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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