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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00736671
Recruitment Status : Completed
First Posted : August 18, 2008
Last Update Posted : March 4, 2016
Sponsor:
Information provided by (Responsible Party):
Nicolaas Bohnen, MD, PhD, University of Michigan

Tracking Information
First Submitted Date August 15, 2008
First Posted Date August 18, 2008
Last Update Posted Date March 4, 2016
Study Start Date July 2006
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Striatal and Extra-striatal Mechanisms of Falling in Parkinson's Disease
Official Title Striatal and Extra-striatal Mechanisms of Falling in Parkinson's Disease
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.
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
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Parkinson's Disease
Intervention Not Provided
Study Groups/Cohorts
  • Observational Parkinson's Disease
    Observational study of subjects with Parkinson disease
  • Observational Normal Control aubjects
    Observational study of normal control subjects
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 1, 2012)
88
Original Estimated Enrollment
 (submitted: August 15, 2008)
100
Actual Study Completion Date August 2010
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 50 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00736671
Other Study ID Numbers HUM00003450
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Nicolaas Bohnen, MD, PhD, University of Michigan
Study Sponsor University of Michigan
Collaborators Not Provided
Investigators
Principal Investigator: Nicolaas Bohnen VAAAHS
PRS Account University of Michigan
Verification Date March 2016