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Relationship Between Symptoms, Retinal Morphology, and the Nigrostriatal Dopamine System in Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT02443779
Recruitment Status : Active, not recruiting
First Posted : May 14, 2015
Last Update Posted : October 13, 2017
Sponsor:
Collaborator:
Wills Eye Hospital
Information provided by (Responsible Party):
Thomas Jefferson University

Brief Summary:
The purpose of this study is to examine if a correlation exists between findings from brain imaging studies of the status of the dopamine system in the brain using DaTscan and SPECT imaging, clinical symptoms of Parkinson's disease, and changes in the structure of the retina as detected by optical coherence tomography (OCT) in recently diagnosed and more advanced Parkinson's disease patients.

Condition or disease
Parkinson's Disease

Study Type : Observational
Estimated Enrollment : 12 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Relationship Between Symptom Severity, Retinal Morphology, and the Nigrostriatal Dopamine System in the Brain in Parkinson's Disease
Study Start Date : December 2015
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Group/Cohort
Early Parkinson's disease patients
All subjects will undergo a complete neuro-ophthalmological examination, including assessment of best-corrected visual acuity, ocular motility, pupillary reflexes, slit-lamp biomicroscopy, intraocular pressure (IOP) measurement, and dilated fundus examination, followed by an optical coherence tomography study. Subjects will also have a DaTscan for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging. A clinical examination will also be performed in order to document motor and cognitive functioning.
Advanced Parkinson's disease patients
All subjects will undergo a complete neuro-ophthalmological examination, including assessment of best-corrected visual acuity, ocular motility, pupillary reflexes, slit-lamp biomicroscopy, intraocular pressure (IOP) measurement, and dilated fundus examination, followed by an optical coherence tomography study. Subjects will also have a DaTscan for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging. A clinical examination will also be performed in order to document motor and cognitive functioning.



Primary Outcome Measures :
  1. OCT results [ Time Frame: 1 day ]
    OCT measures including measurements of the thickness (microns) of specific retinal layers including RNFL, ganglion cell layer, inner plexiform layer, inner nuclear layer, outer plexiform layer, outer nuclear layer, photoreceptors, and retinal pigment epithelium.

  2. DaTscan results [ Time Frame: 1 day ]
    Striatal binding ratios will be calculated for striatal regions of interest.

  3. Clinical examination results [ Time Frame: 1 day ]
    UPDRS motor score



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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population will be Parkinson's disease patients (Hoehn and Yahr stage 1 - 3). One study group will be subjects (N = 6) with early PD who will be within 3 years from diagnosis and not requiring dopaminergic therapy. These subjects will need to have Unified Parkinson's Disease Rating Scale motor scores of 10 - 15. The second study group will be subjects (N = 6) with more advanced PD and will have had PD for at least 5 years and will need to have Unified Parkinson's Disease Rating Scale motor scores of > 20.
Criteria

Inclusion Criteria:

  1. Willing and able to give informed consent.
  2. Between the ages of 50-80 years old.
  3. Male or female with idiopathic PD who fulfill UK PD Society brain bank criteria for diagnosis of Parkinson's disease.
  4. Early stage subjects will need to have Unified Parkinson's Disease Rating Scale (UPDRS) motor scores of < 10, be within 3 years of diagnosis, and not requiring dopaminergic therapy
  5. Later stage subjects will need to have Unified Parkinson's Disease Rating Scale motor scores of > 20 and be > 5 years from diagnosis
  6. If female, one of the following three scenarios must apply:

    • at least two years post-menopausal
    • surgically sterile
    • negative urine pregnancy test, and following a reliable method of birth control (oral contraceptive, intrauterine device, contraceptive implant, barrier, or abstinence) for at least two months prior to entry, and agreeing both to follow a reliable method of birth control, and (if relevant) to desist from breast feeding during, and for two weeks following tracer administration.

Exclusion Criteria:

  1. Abrupt onset of Parkinsonism
  2. 'Other Parkinson-like syndromes (e.g. progressive supranuclear palsy, multiple system atrophy)
  3. Any condition that would preclude successful completion of SPECT scanning
  4. Use of anti-coagulant therapy
  5. Any clinically significant eye disease that would complicate interpretation of OCT data
  6. Use of any drugs that would alter or interfere with tracer binding for SPECT imaging studies (ex., cocaine, amphetamines, methylphenidate, ephedrine, phentermine, bupropion, fentanyl, selective serotonin reuptake inhibitors).
  7. Known sensitivity to the imaging agent or to Lugol's solution or to potassium perchlorate.
  8. History or presence of severe renal disease.

Information from the National Library of Medicine

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): NCT02443779


Locations
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
Wills Eye Hospital
Investigators
Principal Investigator: Jay S Schneider, PhD Thomas Jefferson University

Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT02443779     History of Changes
Other Study ID Numbers: 15D.060
First Posted: May 14, 2015    Key Record Dates
Last Update Posted: October 13, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Dopamine
Dopamine Agents
Cardiotonic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents