Magnetic Resonance Spectroscopy in Autonomic Failure

NCT01607268 | Terminated

• 1 other identifier: 120574
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Pure Autonomic Failure; Multiple System Atrophy

Keywords

autonomic failure; mangenetic resonance; neurochemistry; neurotransmitter; glutamate

Outcome Measures

Primary Outcomes (1)

• 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.

  0.5-1.5 hours

Secondary Outcomes (5)

• Myoinositol Levels

  0.5-1.5 hours

• GABA Levels

  0.5-1.5 hours

• Creatinine Levels

  0.5-1.5 Hours

• Choline Levels

  0.5-1.5 Hours

• Glutamate Levels

  0.5-1.5 Hours

Study Arms (2)

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

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

Interventions

Magnetic Resonance Spectroscopy Imaging PROCEDURE

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.

Also known as: MRS

Multiple System Atrophy; Pure Autonomic Failure

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37211, United States

Location

MeSH Terms

Conditions

Pure Autonomic Failure; Multiple System Atrophy

Condition Hierarchy (Ancestors)

Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Italo Biaggioni, MD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Associate Director Clinical Research Center

Study Record Dates

• First Submitted: May 17, 2012
• First Posted: May 30, 2012
• Study Start: July 1, 2012
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: January 18, 2017

Record last verified: 2017-01

Locations

US (1)