Magnetic Resonance Spectroscopy in Autonomic Failure

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ClinicalTrials.gov Identifier: NCT01607268

Recruitment Status : Terminated (Could not enroll enough participants, and lost funding.)

First Posted : May 30, 2012

Last Update Posted : January 18, 2017

Sponsor:

Information provided by (Responsible Party):

Italo Biaggioni, Vanderbilt University

Study Description

Brief 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. 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.

Condition or disease	Intervention/treatment
Pure Autonomic Failure Multiple System Atrophy	Procedure: Magnetic Resonance Spectroscopy Imaging

Study Design


Study Type :	Observational
Actual Enrollment :	6 participants
Observational Model:	Case Control
Time Perspective:	Cross-Sectional
Official Title:	Proton Magnetic Resonance Spectroscopy in Primary Autonomic Failure
Study Start Date :	July 2012
Actual Primary Completion Date :	January 2017
Actual Study Completion Date :	January 2017

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Multiple system atrophy

Genetic and Rare Diseases Information Center resources: Multiple System Atrophy Pure Autonomic Failure

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	Intervention/treatment
Pure Autonomic Failure Pure autonomic failure is a type of primary autonomic failure characterized by peripheral autonomic nervous system impairment.	Procedure: Magnetic Resonance Spectroscopy Imaging 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. Other Name: MRS
Multiple System Atrophy Multiple system atrophy is a type of primary autonomic failure characterized by central autonomic nervous system impairment.	Procedure: Magnetic Resonance Spectroscopy Imaging 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. Other Name: MRS

Group/Cohort

Intervention/treatment

Pure Autonomic Failure

Pure autonomic failure is a type of primary autonomic failure characterized by peripheral autonomic nervous system impairment.

Procedure: Magnetic Resonance Spectroscopy Imaging

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.

Other Name: MRS

Multiple System Atrophy

Multiple system atrophy is a type of primary autonomic failure characterized by central autonomic nervous system impairment.

Procedure: Magnetic Resonance Spectroscopy Imaging

Other Name: MRS

Outcome Measures

Primary Outcome Measures :

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.

Secondary Outcome Measures :

Myoinositol Levels [ Time Frame: 0.5-1.5 hours ]
Differences in levels of myoinositol in the dorsal medulla pure autonomic failure versus multiple system atrophy patients.
GABA Levels [ Time Frame: 0.5-1.5 hours ]
Differences in levels of the neurotransmitter GABA in the dorsal medulla of pure autonomic failure versus multiple system atrophy patients.
Creatinine Levels [ Time Frame: 0.5-1.5 Hours ]
Differences in levels of creatinine-containing compounds in the dorsal medulla of pure autonomic failure versus multiple system atrophy patients.
Choline Levels [ Time Frame: 0.5-1.5 Hours ]
Differences in levels of choline-containing compounds in the dorsal medulla of pure autonomic failure versus multiple system atrophy patients.
Glutamate Levels [ Time Frame: 0.5-1.5 Hours ]
Differences in levels of glutamate in the dorsal medulla of pure autonomic failure versus multiple system atrophy patients.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01607268

Locations


United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37211

Sponsors and Collaborators

Vanderbilt University

Investigators


Principal Investigator:	Italo Biaggioni, MD	Vanderbilt University

More Information

Additional Information:

Vanderbilt Autonomic Dysfunction Center This link exits the ClinicalTrials.gov site


Responsible Party:	Italo Biaggioni, Professor and Associate Director Clinical Research Center, Vanderbilt University
ClinicalTrials.gov Identifier:	NCT01607268 History of Changes
Other Study ID Numbers:	120574
First Posted:	May 30, 2012 Key Record Dates
Last Update Posted:	January 18, 2017
Last Verified:	January 2017

Keywords provided by Italo Biaggioni, Vanderbilt University:


autonomic failure mangenetic resonance neurochemistry neurotransmitter glutamate

Additional relevant MeSH terms:


Atrophy Multiple System Atrophy Shy-Drager Syndrome Pure Autonomic Failure Pathological Conditions, Anatomical Primary Dysautonomias Autonomic Nervous System Diseases Nervous System Diseases Basal Ganglia Diseases Brain Diseases	Central Nervous System Diseases Movement Disorders Neurodegenerative Diseases Hypotension Vascular Diseases Cardiovascular Diseases Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs

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