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

NCT01692561 | Completed DMC

• 2 other identifiers: WFMCMRI 001JEF MRI 001
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysautonomia

Keywords

Dysautonomia; Postural orthostatic tachycardic hypotension; Neurocardiogenic vasovagal syncope

Outcome Measures

Primary Outcomes (1)

• Assessment of the implication of dysautonomia on the brain and better evaluate its potential mechanistic process.

  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.

  Assessments will occur in a one and a half hour visit.

Study Arms (4)

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 Criteria

• Age: 9 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

A combination of male and female subjects who are healthy or ahve dysautonomia/

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (1)

• Fortunato JE, Laurienti PJ, Wagoner AL, Shaltout HA, Diz DI, Silfer JL, Burdette JH. Children with chronic nausea and orthostatic intolerance have unique brain network organization: A case-control trial. Neurogastroenterol Motil. 2022 Apr;34(4):e14271. doi: 10.1111/nmo.14271. Epub 2021 Oct 4.

  PMID: 34606665 DERIVED

MeSH Terms

Conditions

Autonomic Nervous System Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases

Study Officials

• Debra Diz, M.D.

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2012
• First Posted: September 25, 2012
• Study Start: August 1, 2012
• Primary Completion: June 11, 2013
• Study Completion: June 11, 2013
• Last Updated: April 27, 2018

Record last verified: 2018-04

Locations

US (1)