Fatigue and Cardiac Sympathetic Denervation in Parkinson Disease (Fatigue)
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|ClinicalTrials.gov Identifier: NCT02034318|
Recruitment Status : Completed
First Posted : January 13, 2014
Last Update Posted : March 10, 2015
|Condition or disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||25 participants|
|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|
- 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).
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
|United States, Florida|
|University of Miami|
|Miami, Florida, United States, 33136|