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Fatigue and Cardiac Sympathetic Denervation in Parkinson Disease (Fatigue)

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: NCT02034318
Recruitment Status : Completed
First Posted : January 13, 2014
Last Update Posted : March 10, 2015
Sponsor:
Information provided by (Responsible Party):
Carlos Singer, University of Miami

Brief Summary:
The purpose of this research study is to learn about a possible association between cardiac denervation (the breaking down of nerves in the heart) and the development of fatigue in Parkinson's disease (PD).

Condition or disease
Parkinson's Disease

Detailed Description:

This investigator-initiated study is meant to determine whether a correlation exists between cardiac denervation (as assessed by 123I-mIBG scans) and subjective ratings of fatigue in patients with Parkinson disease. Subjects will be recruited from the Movement Disorder section of the department of Neurology. Subjects fulfilling inclusion/exclusion criteria will undergo testing to exclude confounding factors such as depression or sleep dysfunction. Subjects will also complete several validated measures of fatigue. These measures will be correlated to a calculated ratio obtained from an 123I-mIBG scan to provide an indication of the relative denervation present in the subject. These findings will serve as pilot data for a larger prospective study exploring this topic.

Patients who are found to have possible signs of depression based on the depression ratings scales performed during the study will be provided with a referral to a mental health specialist for further evaluation and treatment. Patients who endorse thoughts of suicide or homicide will be referred to the Jackson Memorial Mental Health Crisis Intervention Center for acute evaluation.

The radiopharmaceutical 123-I-mIBG has been approved for assessing sympathetic activity in neuroendocrine tumors and is currently undergoing investigation in the study of sympathetic innervations of the heart in heart failure and a variety of other electrophysiologic abnormalities of the heart, in which sympathetic innervations may be playing a role. The subject will be exposed to small doses of radiation during the course of the scan. Nuclear medicine has been used for more than five decades, and there are no known long-term adverse effects from such low-dose exposure. Allergic reactions to radiopharmaceuticals may occur but are extremely rare and are usually mild. This risk will be minimized by excluding individuals with previous allergic reactions to iodine. Injection of the radiotracer may cause slight pain and redness which should rapidly resolve. Some medications may have to be stopped a few hours before the 123-I-mIBG scan is performed.

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Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Fatigue and Cardiac Sympathetic Denervation in Parkinson Disease
Study Start Date : March 2009
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Comparison of cardiac uptake with fatigue severity score [ Time Frame: six weeks ]
    The purpose of this research study is to learn about a possible association between cardiac denervation (the breaking down of nerves in the heart) and the development of fatigue in Parkinson's disease (PD).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Elderly/aged Outpatients
Criteria

Inclusion Criteria:

  • Have been diagnosed with Parkinson's disease within the past 5 years
  • Have mild to moderate Parkinson's disease (H&Y Stage ≤ 3)

Exclusion Criteria:

  • Are currently pregnant or lactating
  • Fulfill DSM IV TR criteria for major depression or dysthymia
  • Fulfill DSM criteria for generalized anxiety disorder or panic disorder
  • Are currently taking a medication known to affect 123I-mIBG uptake (See Appendix 1)
  • Have a history of previous relevant cardiac disease, or any clinically significant abnormalities on routine chest radiography, electrocardiography, or cardiac ultrasonography
  • Have active lung disease, including asthma, COPD, or pneumonia
  • Have diabetes mellitus
  • Have congestive heart failure
  • Have an active systemic infection
  • History of allergic reaction to radionuclide agent or have allergy to iodine

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): NCT02034318


Locations
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United States, Florida
University of Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
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Responsible Party: Carlos Singer, Carlos Singer, MD, University of Miami
ClinicalTrials.gov Identifier: NCT02034318    
Other Study ID Numbers: 20090004
First Posted: January 13, 2014    Key Record Dates
Last Update Posted: March 10, 2015
Last Verified: March 2015
Keywords provided by Carlos Singer, University of Miami:
Fatigue
Cardiac Sympathetic Denervation
Parkinson Disease
Additional relevant MeSH terms:
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Parkinson Disease
Fatigue
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases