Retinal Function in Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:

Intrinsically Photosensitive Retinal Ganglion Cells in Parkinson's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01010074
• Other study ID #: PD001
• Status: Recruiting
• Phase: N/A
• First received: November 6, 2009
• Last updated: November 6, 2009
• Start date: October 2009
• Est. completion date: December 2010

Study information

• Verified date: November 2009
• Source: Edward Hines Jr. VA Hospital
• Contact: Bruce Ira Gaynes, OD, PharmD
• Phone: 708-216-6262
• Email: Bruce.Gaynes[@]va.gov
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

Parkinson's disease (PD) is a neurodegenerative disorder characterized by muscle rigidity, tremor, a slowing of physical movement (bradykinesia) and, in extreme cases, a loss of physical movement. The primary symptoms are the results of decreased stimulation of the motor cortex arising from the basal ganglia normally caused by the insufficient formation and action of dopamine, which is produced in the dopaminergic neurons of the brain. Secondary symptoms may include high level cognitive dysfunction and subtle language problems. Included in the symptomatology experienced by patients with PD, visual abnormalities are not uncommon. Visual changes among patients with PD appear not only dynamic in nature, but differentially affected based on the course of the disease and, perhaps more importantly, its treatment. Parkinson's disease has significant ramifications not only in observation of irregularities in vision, but how vision interacts with entrainment of the circadian clock. The purpose of this study is to examine the relationship between PD and operation of a unique set of retinal cells known to regulate the circadian clock and sleep-wake cycles in human subjects.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria: age 18-64 best corrected visual acuity of 20/25 or better in each eye -

Exclusion Criteria: evidence of any form of eye disease, inability to understand and sign informed consent.

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Locations

Country	Name	City	State
United States	Hines VA Medical Center	Hines	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pupillary threshold		one	No