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PharmacoMRI of Parkinson 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: NCT01528592
Recruitment Status : Completed
First Posted : February 8, 2012
Results First Posted : December 24, 2013
Last Update Posted : May 3, 2018
Sponsor:
Information provided by (Responsible Party):
Darren Gitelman, Northwestern University

Study Description
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Brief Summary:
Based on studies showing better responsiveness of motor versus cognitive symptoms to Parkinson's Disease medication, also known as dopaminergic treatments, the investigators hypothesize that comparison of resting state networks in the on versus off medication state in Parkinson's Disease patients will show greater effects on brain networks associated with motor control.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: Carbidopa-Levodopa Not Applicable

Detailed Description:
Subject participation includes two 25-30 minute MRI scans. The subject will arrive in the "off" state (PD medications withheld for approximately 12 hours prior to the scan). Following the initial scan, the subject will receive 125% of his or her usual daily morning dose of PD medications which is calculated as levodopa dose equivalents (LDE) and is given as carbidopa-levodopa. The subject will then wait for an hour allowing for the medication to begin working. During this time the subject will complete cognitive assessments, questionnaires regarding the history and current state of PD, and motor assessments. The subject will then undergo a second MRI scan of approximately 25-30 minutes. The subject after completing the second MRI scan is free to leave. The entire study is approximately 2 and 1/2 hours long.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Pilot Study of the Drug Effects on Brain Connectivity of Parkinson's Disease
Study Start Date : June 2011
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: On / Off medication
Subjects undergo MRI scanning in the medication off state and 1 hour after receiving medications.
 Drug: Carbidopa-Levodopa
Equivalent amount of carbidopa-levodopa will be provide to you


Outcome Measures
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Primary Outcome Measures :
  1. Correlation Coefficient Between UPDRS III Score and Independent Components Analysis Network Strength in Left Parietal Cortex. [ Time Frame: 1 hour ]
    Correlation coefficient between UPDRS III score and independent components analysis network strength in left parietal cortex. UPDRS III is the Unified Parkinson's Disease Rating Scale composite motor score.


Eligibility Criteria
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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Idiopathic Parkinson's Disease (PD)
  • Older than 30 years of age at the time of diagnosis
  • Hoehn and Yahr stage greater than or equal to 2.5
  • PD duration greater than 3 years
  • Stable regimen of PD medications for at least 2 weeks prior to imaging
  • PD medications include carbidopa-levodopa

Exclusion Criteria:

  • Patients with a diagnosis of other neurodegenerative conditions
  • Patients unwilling or unable to give informed consent
  • Contraindications (cardiac pacemaker, etc.) or inability (e.g., claustrophobia) to undergo MRI scan
Contacts and Locations
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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): NCT01528592


Locations
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United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
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Principal Investigator: Darren R Gitelman, MD Northwestern University
More Information
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Responsible Party: Darren Gitelman, Medical Doctor, Associate Professor of Neurology and Physiology, Northwestern University
ClinicalTrials.gov Identifier: NCT01528592    
Other Study ID Numbers: Ruby-60029592
First Posted: February 8, 2012    Key Record Dates
Results First Posted: December 24, 2013
Last Update Posted: May 3, 2018
Last Verified: April 2018
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
Synucleinopathies
Neurodegenerative Diseases
Levodopa
Carbidopa
Carbidopa, levodopa drug combination
 Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Aromatic Amino Acid Decarboxylase Inhibitors
Enzyme Inhibitors
Adjuvants, Immunologic
Immunologic Factors
Dopamine Agonists