- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00736671
Striatal and Extra-striatal Mechanisms of Falling in Parkinson's Disease
March 2, 2016 updated by: Nicolaas Bohnen, MD, PhD, University of Michigan
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.
Study Overview
Status
Completed
Conditions
Detailed Description
Although most research in PD has a focus on presynaptic dopaminergic denervation, new lessons may be learned by exploring to what extent alterations in non-motor and non-dopaminergic systems may play a role in the balance impairment in this disorder.
This project is designed to evaluate striatal pre-synaptic dopaminergic, cortical, thalamic, and brainstem cholinergic, cognitive, and oculomotor mechanisms underlying the risk of falling and imbalance in PD.
The proposed study will exploit advances in our center in the development of dynamic biomathematical modeling of electronic platform data, application of specialized cognitive and oculomotor assessments, and positron emission tomography (PET).
This novel multi-system approach holds promise for understanding mechanisms of falling in PD beyond pre-synaptic dopaminergic nigrostriatal denervation.
Study Type
Observational
Enrollment (Actual)
88
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Michigan
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Ann Arbor, Michigan, United States, 48106
- University of Michigan Functional Neuroimaging, Cognnitive and Mobility Laboratory
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
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.
Description
Inclusion Criteria:
- Subjects considered for inclusion will be female or male subjects either currently enrolled or eligible for care at the VA aged 50-85 years, or community volunteers.
- 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.
- No exclusion criteria shall be based on race, ethnicity, gender, or asymptomatic HIV status.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Observational Parkinson's Disease
Observational study of subjects with Parkinson disease
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Observational Normal Control aubjects
Observational study of normal control subjects
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nicolaas Bohnen, VAAAHS
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2006
Primary Completion (Actual)
April 1, 2010
Study Completion (Actual)
August 1, 2010
Study Registration Dates
First Submitted
August 15, 2008
First Submitted That Met QC Criteria
August 15, 2008
First Posted (Estimate)
August 18, 2008
Study Record Updates
Last Update Posted (Estimate)
March 4, 2016
Last Update Submitted That Met QC Criteria
March 2, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00003450
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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