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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nicolaas Bohnen, MD, PhD, University of Michigan
ClinicalTrials.gov Identifier:
NCT00736671
First received: August 15, 2008
Last updated: May 1, 2012
Last verified: May 2012
History of Changes
  Purpose

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 Intervention
Parkinson's Disease
 Other: This is an observational study. Medical and radiological records will only be observed/reviewed.

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Michigan:

Enrollment: 88
Study Start Date: July 2006
Study Completion Date: August 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Parkinson's Disease Other: This is an observational study. Medical and radiological records will only be observed/reviewed.
After completion of the PET scan the procedure results will be reviewed.
Normal Control Other: This is an observational study. Medical and radiological records will only be observed/reviewed.
After completion of the PET scan the procedure results will be reviewed.

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
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.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00736671

Locations
United States, Michigan
University of Michigan Functional Neuroimaging, Cognnitive and Mobility Laboratory
Ann Arbor, Michigan, United States, 48106
Sponsors and Collaborators
University of Michigan
  More Information

No publications provided

Responsible Party: Nicolaas Bohnen, MD, PhD, Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT00736671     History of Changes
Other Study ID Numbers: HUM00003450
Study First Received: August 15, 2008
Last Updated: May 1, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on May 19, 2013