DysautonomiaNCT01692561
MRI to Assess the Effects of Dysautonomia and Chronic Nausea on Brain Transmitters
An observational study of Dysautonomia, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Dysautonomia
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to 11 Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: A combination of male and female subjects who are healthy or ahve dysautonomia/
Who may be able to join
- subjects who have completed tilt autonomic testing
- subjects from 9 - 18 years of age
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
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
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
- Medical subject headings
- Autonomic Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessments will occur in a one and a half hour visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2012 (estimated)
- Study startAug 2012
- Primary completion11 Jun 2013
- Study completion11 Jun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DysautonomiaStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Debra Diz, M.D., Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01692561
- Sponsor's protocol ID
- WFMCMRI 001
- Other IDs
- JEF MRI 001
- Status last verified
- Apr 2018
- First submitted
- 11 Sep 2012
- Last updated
- 27 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 34606665
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01692561
- Acronym / sponsor ID
- WFMCMRI 001
- Conditions
- Dysautonomia
- Keywords
- Dysautonomia, Postural orthostatic tachycardic hypotension, Neurocardiogenic vasovagal syncope
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Aug 2012 (actual)
- Primary completion
- 11 Jun 2013 (actual)
- Study completion
- 11 Jun 2013 (actual)
- First posted
- 25 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 9 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- A combination of male and female subjects who are healthy or ahve dysautonomia/
Key inclusion criteria (2 listed)
- subjects who have completed tilt autonomic testing
- subjects from 9 - 18 years of age
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2018.
- Derived from this study: PubMed 34606665Fortunato 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Debra Diz, M.D. principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dysautonomia, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01692561, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2018.