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Magnetic Resonance Spectroscopy in Autonomic Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date May 17, 2012
First Posted Date May 30, 2012
Last Update Posted Date January 18, 2017
Study Start Date July 2012
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 24, 2012)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01607268 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 24, 2012)
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Magnetic Resonance Spectroscopy in Autonomic Failure
Official Title Proton Magnetic Resonance Spectroscopy in Primary Autonomic Failure
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Pure Autonomic Failure
  • Multiple System Atrophy
Intervention 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
Study Groups/Cohorts
  • Pure Autonomic Failure
    Pure autonomic failure is a type of primary autonomic failure characterized by peripheral autonomic nervous system impairment.
    Intervention: 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.
    Intervention: Procedure: Magnetic Resonance Spectroscopy Imaging
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: January 16, 2017)
6
Original Estimated Enrollment
 (submitted: May 24, 2012)
26
Actual Study Completion Date January 2017
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01607268
Other Study ID Numbers 120574
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Italo Biaggioni, Vanderbilt University
Study Sponsor Vanderbilt University
Collaborators Not Provided
Investigators
Principal Investigator: Italo Biaggioni, MD Vanderbilt University
PRS Account Vanderbilt University Medical Center
Verification Date January 2017