Magnetic Resonance Spectroscopy in Autonomic Failure

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Vanderbilt University
Sponsor:
Information provided by (Responsible Party):
Italo Biaggioni, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01607268
First received: May 17, 2012
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

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 Intervention
Pure Autonomic Failure
Multiple System Atrophy
Procedure: Magnetic Resonance Spectroscopy Imaging

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Proton Magnetic Resonance Spectroscopy in Primary Autonomic Failure

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • N-Acetylaspartate Levels [ Time Frame: 0.5-1.5 hours ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Differences in levels of glutamate in the dorsal medulla of pure autonomic failure versus multiple system atrophy patients.


Estimated Enrollment: 26
Study Start Date: July 2012
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01607268

Contacts
Contact: Bonnie K Black, RN 615-343-6862 bonnie.black@Vanderbilt.edu

Locations
United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37211
Contact: Bonnie Black, RN    615-343-6862    bonnie.black@vanderbilt.edu   
Sub-Investigator: Alfredo Gamboa, MD         
Sub-Investigator: Amy C Arnold, PhD         
Principal Investigator: Italo Biaggioni, MD         
Sub-Investigator: Andre Diedrich, MD, PhD         
Sub-Investigator: Cyndya Shibao, MD         
Sub-Investigator: David Robertson, MD         
Sub-Investigator: Emily Garland, PhD         
Sub-Investigator: Luis E Okamoto, MD         
Sub-Investigator: Satish R Raj, MD         
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Italo Biaggioni, MD Vanderbilt University
  More Information

Additional Information:
No publications provided

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
Study First Received: May 17, 2012
Last Updated: May 27, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Vanderbilt University:
autonomic failure
mangenetic resonance
neurochemistry
neurotransmitter
glutamate

Additional relevant MeSH terms:
Multiple System Atrophy
Shy-Drager Syndrome
Atrophy
Pure Autonomic Failure
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
Pathological Conditions, Anatomical
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 19, 2014