Pure Autonomic FailureNCT01607268
Magnetic Resonance Spectroscopy in Autonomic Failure
An observational study of Pure Autonomic Failure and Multiple System Atrophy, run by Vanderbilt University at 1 site in United States.
Trial summary
This research study will be conducted in patients with primary autonomic failure, a disabling condition that is associated with low blood pressure upon standing. These patients are also not able to control for changes in their blood pressure due to a loss of cardiovascular reflexes that are mediated within the brain. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pure Autonomic Failure, Multiple System Atrophy
- What is being tested?
- Magnetic Resonance Spectroscopy Imaging
- Type of treatment
- Surgery or procedure
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Jan 2017
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary autonomic failure patients will be recruited from patients already in the hospital participating in the approved protocol "The Evaluation and Treatment of Autonomic Failure." Prospective participants come from several sources including clinic patients, former patients, referrals from other physicians, and subjects that read about the Autonomic Dysfunction Center on the Vanderbilt website.
Who may be able to join
- Patients with primary autonomic failure who are already participating in the approved Vanderbilt study "Evaluation and Treatment of Autonomic Failure"
- Males and females of all races between 18 and 80 years of age
- Able and willing to provide informed consent
Who cannot join
- Pregnant women
- Patients with diagnosed Parkinson's Disease or secondary forms of autonomic failure
- Patients with severe claustrophobia
- Patients taking medications known to affect brain neurotransmitter levels [e.g., anti-depressants, barbiturates, benzodiazepines, gabapentin, namenda, sinemet]
- Patients with implanted medical devices [e.g., pacemakers, metal clips, cochlear implants, orthopedic hardware], lead-based tattoos or pieces of metal close to or in an important organ
- High-risk patients [e.g., heart failure, symptomatic coronary artery disease, liver impairment, history of stroke or myocardial infarction]
- Inability to give or withdraw informed consent
- Other factors which in the investigator's opinion would prevent the subject from completing the protocol including significant abnormalities in clinical, mental, or laboratory testing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Proton Magnetic Resonance Spectroscopy in Primary Autonomic Failure
This research study will be conducted in patients with primary autonomic failure, a disabling condition that is associated with low blood pressure upon standing. These patients are also not able to control for changes in their blood pressure due to a loss of cardiovascular reflexes that are mediated within the brain. The purpose of this study is to determine whether magnetic resonance spectroscopy (MRS), a non-invasive imaging technique, can measure levels of chemicals (neurotransmitters) in the dorsal medulla, a brain area important for control of cardiovascular function, in autonomic failure patients. Importantly, this study will determine whether there are differences in brain chemicals between patients with peripheral versus central origins of their autonomic failure. The hypothesis is that the neurotransmitter profile in the medulla will be intact in patients with peripheral autonomic failure compared to those with central impairment. Overall, this study will provide insight into understanding the mechanisms involved in autonomic failure and will determine whether a single session of MRS imaging can improve the ability to make an accurate diagnosis in these patients. This would lessen the need for more extensive and invasive clinical testing.
- Conditions
- Pure Autonomic Failure, Multiple System Atrophy
- Being tested
- Magnetic Resonance Spectroscopy Imaging
- Keywords
- autonomic failure, mangenetic resonance, neurochemistry, neurotransmitter, glutamate
- Medical subject headings
- Pure Autonomic Failure, Multiple System Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Spectroscopy ImagingProcedure or surgery
Also called MRS
Proton magnetic resonance spectroscopy [1H-MRS] is an emerging imaging tool that allows for non-invasive assessment of brain neurochemistry in human subjects. This technique allows for in vivo quantification of the concentration of neurotransmitters and metabolites in discrete brain regions through detection of hydrogen nuclei in these molecules. Autonomic failure patients will undergo a single imaging session lasting 30 to 90 minutes (0.5-1.5 hours) in the Vanderbilt Human Imaging Institute.
| Study group | Role | What they receive |
|---|---|---|
| Pure Autonomic Failure | Pure autonomic failure is a type of primary autonomic failure characterized by peripheral autonomic nervous system impairment. Receives: Procedure: Magnetic Resonance Spectroscopy Imaging | |
| Multiple System Atrophy | Multiple system atrophy is a type of primary autonomic failure characterized by central autonomic nervous system impairment. Receives: Procedure: Magnetic Resonance Spectroscopy Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
N-Acetylaspartate Levels
Differences in levels of N-acetylaspartate in the dorsal medulla of pure autonomic failure versus multiple system atrophy patients using single session imaging.
Measured: 0.5-1.5 hours
Secondary outcomes (5)
Myoinositol Levels
Differences in levels of myoinositol in the dorsal medulla pure autonomic failure versus multiple system atrophy patients.
Measured: 0.5-1.5 hours
GABA Levels
Differences in levels of the neurotransmitter GABA in the dorsal medulla of pure autonomic failure versus multiple system atrophy patients.
Measured: 0.5-1.5 hours
Creatinine Levels
Differences in levels of creatinine-containing compounds in the dorsal medulla of pure autonomic failure versus multiple system atrophy patients.
Measured: 0.5-1.5 Hours
Choline Levels
Differences in levels of choline-containing compounds in the dorsal medulla of pure autonomic failure versus multiple system atrophy patients.
Measured: 0.5-1.5 Hours
Glutamate Levels
Differences in levels of glutamate in the dorsal medulla of pure autonomic failure versus multiple system atrophy patients.
Measured: 0.5-1.5 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2012 (estimated)
- Study startJul 2012
- Primary completionJan 2017
- Study completionJan 2017
Why it stopped: Could not enroll enough participants, and lost funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pure Autonomic FailureStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Italo Biaggioni, Vanderbilt University
- Investigators
- Italo Biaggioni, MD, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01607268
- Sponsor's protocol ID
- 120574
- Status last verified
- Jan 2017
- First submitted
- 17 May 2012
- Last updated
- 18 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proton Magnetic Resonance Spectroscopy in Primary Autonomic Failure
- ClinicalTrials.gov ID
- NCT01607268
- Acronym / sponsor ID
- 120574
- Conditions
- Pure Autonomic Failure, Multiple System Atrophy
- Keywords
- autonomic failure, mangenetic resonance, neurochemistry, neurotransmitter, glutamate
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Could not enroll enough participants, and lost funding.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 30 May 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.
This research study will be conducted in patients with primary autonomic failure, a disabling condition that is associated with low blood pressure upon standing. These patients are also not able to control for changes in their blood pressure due to a loss of cardiovascular reflexes that are mediated within the brain. The purpose of this study is to determine whether magnetic resonance spectroscopy (MRS), a non-invasive imaging technique, can measure levels of chemicals (neurotransmitters) in the dorsal medulla, a brain area important for control of cardiovascular function, in autonomic failure patients. Importantly, this study will determine whether there are differences in brain chemicals between patients with peripheral versus central origins of their autonomic failure. The hypothesis is that the neurotransmitter profile in the medulla will be intact in patients with peripheral autonomic failure compared to those with central impairment. Overall, this study will provide insight into understanding the mechanisms involved in autonomic failure and will determine whether a single session of MRS imaging can improve the ability to make an accurate diagnosis in these patients. This would lessen the need for more extensive and invasive clinical testing.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pure Autonomic Failure | – | Procedure: Magnetic Resonance Spectroscopy ImagingPure autonomic failure is a type of primary autonomic failure characterized by peripheral autonomic nervous system impairment. |
| Multiple System Atrophy | – | Procedure: Magnetic Resonance Spectroscopy ImagingMultiple system atrophy is a type of primary autonomic failure characterized by central autonomic nervous system impairment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary autonomic failure patients will be recruited from patients already in the hospital participating in the approved protocol "The Evaluation and Treatment of Autonomic Failure." Prospective participants come from several sources including clinic patients, former patients, referrals from other physicians, and subjects that read about the Autonomic Dysfunction Center on the Vanderbilt website.
Key inclusion criteria (3 listed)
- Patients with primary autonomic failure who are already participating in the approved Vanderbilt study "Evaluation and Treatment of Autonomic Failure"
- Males and females of all races between 18 and 80 years of age
- Able and willing to provide informed consent
Key exclusion criteria (8 listed)
- Pregnant women
- Patients with diagnosed Parkinson's Disease or secondary forms of autonomic failure
- Patients with severe claustrophobia
- Patients taking medications known to affect brain neurotransmitter levels [e.g., anti-depressants, barbiturates, benzodiazepines, gabapentin, namenda, sinemet]
- Patients with implanted medical devices [e.g., pacemakers, metal clips, cochlear implants, orthopedic hardware], lead-based tattoos or pieces of metal close to or in an important organ
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance Spectroscopy ImagingAlso: MRSProton magnetic resonance spectroscopy [1H-MRS] is an emerging imaging tool that allows for non-invasive assessment of brain neurochemistry in human subjects. This technique allows for in vivo quantification of the concentration of neurotransmitters and metabolites in discrete brain regions through detection of hydrogen nuclei in these molecules. Autonomic failure patients will undergo a single imaging session lasting 30 to 90 minutes (0.5-1.5 hours) in the Vanderbilt Human Imaging Institute. | Procedure or surgery | Multiple System Atrophy, Pure Autonomic Failure |
Primary outcome
N-Acetylaspartate Levels
Time frame: 0.5-1.5 hours
Differences in levels of N-acetylaspartate in the dorsal medulla of pure autonomic failure versus multiple system atrophy patients using single session imaging.
5 secondary outcomes
Myoinositol Levels
Time frame: 0.5-1.5 hours
GABA Levels
Time frame: 0.5-1.5 hours
Creatinine Levels
Time frame: 0.5-1.5 Hours
Choline Levels
Time frame: 0.5-1.5 Hours
Glutamate Levels
Time frame: 0.5-1.5 Hours
Results and safety
The study was stopped early (reason given: Could not enroll enough participants, and lost funding.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2017.
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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.
Italo Biaggioni, MD principal investigator
Vanderbilt University
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 Pure Autonomic Failure and Multiple System Atrophy, run by Vanderbilt University 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 3 inclusion and 8 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: stopped early, as of the sponsor's last update on 18 Jan 2017. 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 was stopped early (reason given: Could not enroll enough participants, and lost funding.). Results are not available in the source record.
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?
N-Acetylaspartate Levels (time frame: 0.5-1.5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jan 2017.