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Striatal and Extra-striatal Mechanisms of Falling in Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT00736671
Recruitment Status : Completed
First Posted : August 18, 2008
Last Update Posted : March 4, 2016
Information provided by (Responsible Party):
Nicolaas Bohnen, MD, PhD, University of Michigan

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.

Condition or disease
Parkinson's Disease

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.

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Study Type : Observational
Actual Enrollment : 88 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Striatal and Extra-striatal Mechanisms of Falling in Parkinson's Disease
Study Start Date : July 2006
Actual Primary Completion Date : April 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

Observational Parkinson's Disease
Observational study of subjects with Parkinson disease
Observational Normal Control aubjects
Observational study of normal control subjects

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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.

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): NCT00736671

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United States, Michigan
University of Michigan Functional Neuroimaging, Cognnitive and Mobility Laboratory
Ann Arbor, Michigan, United States, 48106
Sponsors and Collaborators
University of Michigan
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Principal Investigator: Nicolaas Bohnen VAAAHS
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Responsible Party: Nicolaas Bohnen, MD, PhD, Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT00736671    
Other Study ID Numbers: HUM00003450
First Posted: August 18, 2008    Key Record Dates
Last Update Posted: March 4, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases