Sponsor study identifier
observational
166
1 country
1
Study Start
February 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2020
Actual (reported)Study Completion
October 31, 2020
Actual (reported)Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 31, 2020
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 22, 2015
Actual (reported)December 28, 2015
Actual (reported)February 2016
Date type not reportedThis date has not been verified as actual or estimated.
September 2020
Actual (reported)October 31, 2020
Actual (reported)Retinal nerve fiber layer (RNFL) thickness
The results of the RNFL thickness will be expressed in microns in different zones around the optic nerve: temporal, superior, nasal, inferior and global.
Every 6 months from baseline to 3 years
Retinal ganglion cell layer (GCL) thickness
The results of the GCL thickness will be expressed in microns in different zones around the fovea region: temporal- superior, superior, nasal-superior, nasal inferior, inferior, temporal inferior and global.
Every 6 months from baseline to 3 years
• Visual Acuity
Every 6 months from baseline to 3 years
Parkinson's disease is a progressive disorder of the nervous system that affects movement. It develops gradually, with alpha-synuclein deposits in neurons which aggregate into Lewy bodies.
is a degenerative neurological disorder. MSA is associated with the degeneration of nerve cells in specific areas of the brain. This cell degeneration causes problems with movement, balance, and autonomic functions of the body such as bladder control or blood-pressure regulation. Neuronal death probably occurs as a consequence of alpha-synuclein aggregation in oligodendroglia.
a sleep disorder in which you physically act out vivid, often unpleasant dreams with vocal sounds and sudden, often violent arm and leg movements
causes a progressive decline in mental abilities. It may also cause visual hallucinations, which generally take the form of objects, people or animals that aren't there. This can lead to unusual behavior such as having conversations with deceased loved ones. Another indicator of Lewy body dementia may be significant fluctuations in alertness and attention, which may include daytime drowsiness or periods of staring into space. And, like Parkinson's disease, Lewy body dementia can result in rigid muscles, slowed movement and tremors.
Pure autonomic failure is dysfunction of many of the processes controlled by the autonomic nervous system, such as control of blood pressure•Blood pressure may decrease when people stand, and they may sweat less and may have eye problems, retain urine, become constipated, or lose control of bowel movements
We will select patients from our clinic and take advantage of the infrastructure used in the ongoing NIH-funded Natural History of Autonomic Disorders study (ClnicalTrials.gov: NCT01799915), which prospectively follows patients with synucleinopathies with standardized neurological measures overtime.
New York University School of Medicine
New York, New York, 10016, United States
Horacio C Kaufmann, MD
NYU Langone Health
166 participants (actual enrollment reported by the registry).
First Submitted
December 22, 2015
First Posted
December 28, 2015
Study Start
February 2016
Date type not reportedThis date has not been verified as actual or estimated.
Effects of Midodrine and Droxidopa on Splanchnic Capacitance in Autonomic Failure
• Color Discrimination
Every 6 months from baseline to 3 years
• Pupillometry
Every 6 months from baseline to 3 years
• Videonystagmography
Every 6 months from baseline to 3 years
Healthy normals with no neurological involvement
Contact the study team to confirm eligibility.
Primary Completion
September 2020
Actual (reported)Study Completion
October 31, 2020
Actual (reported)Last Updated
December 2, 2020
Record last verified: 2020-12
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Source: ClinicalTrials.gov.
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