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

• ClinicalTrials.gov Identifier: NCT00736671
• Recruitment Status: Completed
• First Posted: August 18, 2008
• Last Update Posted: March 4, 2016
• Sponsor: University of Michigan
• 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
• 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

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

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