Fatigue and Cardiac Sympathetic Denervation in Parkinson Disease

Conditions:Parkinsons Disease
Therapuetic Areas:Neurology
Age Range:18 - 65
Start Date:March 2009
End Date:March 2017
Contact:Carlos Singer, MD

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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).

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.

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

- 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
We found this trial at
Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
Miami, FL
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