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NCT02035761 · ClinicalTrials.gov registry record
PET Imaging Study of Neurochemical and Autonomic Disorders in Multiple System Atrophy (MSA)
A clinical trial, sponsored by University of Michigan.
- Completed
- Registry status
- 23
- Enrollment target
NCT02035761: Completed study, sponsored by University of Michigan.
NCT02035761 is a clinical trial that has completed, run by University of Michigan. The registered enrollment target is 23 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02035761 has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- 23 participants
- Enrollment target
Study Summary
Multiple system atrophy (MSA) is a disorder of the nervous system of unclear cause. In MSA there is degeneration (progressive loss) of nerve cells in several brain and spinal cord regions. The result is a variety of symptoms, from physical (parkinsonism, ataxia, incoordination, falls, slowness) to autonomic (fainting, bladder incontinence, sexual dysfunction) to sleep problems (dream enactment, sleep apnea). This research aims to help us better understand the patterns and timing of nerve degeneration relatively early in the disease, and how this affects symptoms and progression. For instance: 1. Does MSA affect certain nerves that stimulate heart pumping? If so, does the severity of loss of heart nerves affect disease progression and survival? 2. It is thought that MSA does not affect memory and thinking much, unlike other diseases (such as Parkinson's). Is this accurate? Is there loss of nerves that transmit acetylcholine (a neurochemical important in mental functioning)? 3. What can we learn about mood and sleep in MSA, through visualizing the serotonin system in the brain? How does this relate to symptoms that subjects report in these often underappreciated areas? To answer these and other questions, investigators will take images of specific nerves in the brain and heart using Positron Emission Tomography (PET) scans. Such imaging gives us information that cannot be obtained from MRIs and CT scans. We will measure the levels of several nerve cell types: serotonin, acetylcholine, and norepinephrine. Subjects will also have many standardized assessments including quality-of-life and symptom assessments, neurological examination, autonomic assessments, neuropsychological assessments, coordination tests, and even assessments of vision and sense of smell. By pooling these results from many MSA patients, and comparing with other diseases (such as Parkinson's disease) we hope to gain a better understanding of what is happening early in MSA. Such knowledge could be v
Primary Outcome
Early MSA patients vary in their degree of cardiac denervation. A greater degree of cardiac denervation is associated with greater baseline impairment of autonomic, visual and olfactory functions, and predicts a more rapid decline of these functions as well as motor performance.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2011-07 |
| Est. Completion | 2018-09 |
What the finished NCT02035761 record still lists
NCT02035761 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 23 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT02035761 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02035761 about?
NCT02035761 is a clinical study titled "PET Imaging Study of Neurochemical and Autonomic Disorders in Multiple System Atrophy (MSA)". Multiple system atrophy (MSA) is a disorder of the nervous system of unclear cause. In MSA there is degeneration (progressive loss) of nerve cells in several brain and spinal cord regions. The result is a variety of symptoms, from physical (parkinsonism, ataxia, incoordination, falls, slowness) to a...
What is the current status of trial NCT02035761?
This trial is currently completed. The enrollment target is 23 participants. The study started on 2011-07. Estimated completion is 2018-09.
Who is sponsoring clinical trial NCT02035761?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
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