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NCT01692561 · ClinicalTrials.gov registry record
MRI to Assess the Effects of Dysautonomia and Chronic Nausea on Brain Transmitters
A clinical trial, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- 22
- Enrollment target
NCT01692561: Completed study, sponsored by Wake Forest University Health Sciences.
NCT01692561 is a clinical trial that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 22 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01692561 has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- 22 participants
- Enrollment target
Study 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.
Primary Outcome
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
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2012-08 |
| Est. Completion | 2013-06-11 |
What the finished NCT01692561 record still lists
NCT01692561 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 22 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01692561 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01692561 about?
NCT01692561 is a clinical study titled "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 pa...
What is the current status of trial NCT01692561?
This trial is currently completed. The enrollment target is 22 participants. The study started on 2012-08. Estimated completion is 2013-06-11.
Who is sponsoring clinical trial NCT01692561?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
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