Retinal Abnormalities as Biomarker of Disease Progression and Early Diagnosis of Parkinson Disease

NCT02640339 | Completed

• 1 other identifier: 15-01391
• Study Type: observational
• Target: 166
• Locations: 1 country
• Sites: 1

Brief Summary

• To determine whether retinal abnormalities, as measured by high definition optical coherence tomography (HD-OCT) and visual electrophysiology techniques can be used as a clinical biomarker to monitor disease progression overtime in patients with Parkinson disease.
• To establish whether these measures can be used to identify patients with PD in the premotor phase.
• To define the rate of progression of retinal abnormalities in PD (both in the motor and premotor stages) for potential use as a clinical outcome measure

Conditions

Parkinson Disease; Multiple System Atrophy; REM Sleep Behavior Disorder; Pure Autonomic Failure; Dementia With Lewy Bodies

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• • Visual Acuity

  Every 6 months from baseline to 3 years

• • 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

Study Arms (6)

Parkinson Disease

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.

Mutiple system atrophy

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.

REM sleep behavior disorder

a sleep disorder in which you physically act out vivid, often unpleasant dreams with vocal sounds and sudden, often violent arm and leg movements

dementia with Lewy bodies

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

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

Healthy controls

Healthy normals with no neurological involvement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Subjects with PD, MSA and DLB that fulfill current diagnostic criteria.
• Subjects with RBD that have polysomnography-confirmed diagnosis showing evidence of lack of muscle atonia and dream enacting behaviors during REM sleep.
• Subjects with isolated autonomic failure (i.e., no motor deficits) that have evidence of neurogenic orthostatic hypotension and other features of autonomic failure without clinical evidence of cognitive impairment.
• Control subjects with no history of neurological or ophthalmological disorders.

You may not qualify if:

• Subjects with glaucoma, retinopathy, or significant media opacification (e.g., cataracts).
• Subjects with a history of eye surgery or eye trauma
• Inability to comply with the requirements of the study

Sponsors & Collaborators

• NYU Langone Health: lead
• Michael J. Fox Foundation for Parkinson's Research: collaborator

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Multiple System Atrophy; REM Sleep Behavior Disorder; Pure Autonomic Failure; Lewy Body Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Primary Dysautonomias; Autonomic Nervous System Diseases; REM Sleep Parasomnias; Parasomnias; Sleep Wake Disorders; Mental Disorders; Dementia; Neurocognitive Disorders

Study Officials

• Horacio C Kaufmann, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2015
• First Posted: December 28, 2015
• Study Start: February 1, 2016
• Primary Completion: September 1, 2020
• Study Completion: October 31, 2020
• Last Updated: December 2, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)