Striatal and Extra-striatal Mechanisms of Falling in Parkinson's Disease
1 other identifier
observational
88
1 country
1
Brief Summary
This research study will evaluate functions of memory, thinking, eye movements and walking and how these relate to the measurement of certain chemicals (acetylcholine and dopamine) in the brain using an imaging procedure called positron emission tomography (PET). You may know that the brain chemical dopamine, a "neurotransmitter" substance (a chemical messenger that nerve cells need to communicate with each other), is important for the brain to control movements and that the brain chemical acetylcholine may have functions related to mental concentration and attention. At the present time, the investigators have no clear information how these two chemicals in the brain of patients with Parkinson's disease are related to the risk of falling.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2006
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 15, 2008
CompletedFirst Posted
Study publicly available on registry
August 18, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedMarch 4, 2016
March 1, 2016
3.8 years
August 15, 2008
March 2, 2016
Conditions
Study Arms (2)
Observational Parkinson's Disease
Observational study of subjects with Parkinson disease
Observational Normal Control aubjects
Observational study of normal control subjects
Eligibility Criteria
Patients with Parkinson's disease and normal control persons between the ages of 50-85 years are eligible to participate in this study. Participants should be willing and able to comply with study requirements. Normal control persons should not have a history of brain or mental disorders. Both males and females are eligible.
You may qualify if:
- The racial, gender and ethnic characteristics of the proposed subjects population reflect the demographics of the patient population of the VA. However, extra efforts will be made to recruit women and minorities (see table 5).
- Children will be excluded from the study.
You may not qualify if:
- Inability to stand or walk independently (i.e., patients in Hoehn and Yahr stage IV and V).
- Vertiginous disorder.
- Orthostatic hypotension or unstable cardiovascular disease at risk of syncope (drop in systolic blood pressure of \> 20 mm Hg upon standing).
- History of stroke with focal cortical lesions.
- Cerebellar, myelopathic or significant radiculopathy syndrome.
- Diminished light perception in both eyes (\< 20/40 corrected OU).
- Intracranial surgery.
- Subjects who have participated in other research protocols such that their cumulative radiation absorbed dose to whole body, gonads, bone marrow or lens of the eye would exceed 5 Rem, or dose to other body organs is more than 15 Rem in preceding 12 months.
- Pregnancy (beta-HCG test within 48 hours of PET study) or breastfeeding.
- Contra-indications to MRI.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Michigan Functional Neuroimaging, Cognnitive and Mobility Laboratory
Ann Arbor, Michigan, 48106, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nicolaas Bohnen
VAAAHS
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 15, 2008
First Posted
August 18, 2008
Study Start
July 1, 2006
Primary Completion
April 1, 2010
Study Completion
August 1, 2010
Last Updated
March 4, 2016
Record last verified: 2016-03
Data Sharing
- IPD Sharing
- Will not share