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

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
|
- 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.
- 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.

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

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
United States, Tennessee | |
Vanderbilt University | |
Nashville, Tennessee, United States, 37211 |
Principal Investigator: | Italo Biaggioni, MD | Vanderbilt University |
Additional Information:
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 |