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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

Tracking Information
First Submitted Date  ICMJE January 31, 2012
First Posted Date  ICMJE February 8, 2012
Results First Submitted Date  ICMJE November 6, 2013
Results First Posted Date  ICMJE December 24, 2013
Last Update Posted Date May 3, 2018
Study Start Date  ICMJE June 2011
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 4, 2012)
Efficacy of Parkinson's Medication on Brain Connectivity [ Time Frame: 2 and 1/2 hours ]
Two 25-30 minute MRI scans will be conducted. The first when the patient is OFF PD medications for approximately 12 hours and the second following dosage of PD medication thereby being ON PD medication for the 25-30minute scan. There is an hour between the two scans that the patient will complete a series of cognitive assessments: UPDRS, MOCA, medical history, geriatic depression scale, and family history.
Change History Complete list of historical versions of study NCT01528592 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PharmacoMRI of Parkinson Disease
Official Title  ICMJE A Pilot Study of the Drug Effects on Brain Connectivity of Parkinson's Disease
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Parkinson's Disease
Intervention  ICMJE Drug: Carbidopa-Levodopa
Equivalent amount of carbidopa-levodopa will be provide to you
Study Arms  ICMJE Experimental: On / Off medication
Subjects undergo MRI scanning in the medication off state and 1 hour after receiving medications.
Intervention: Drug: Carbidopa-Levodopa
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  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 25, 2012)
18
Original Estimated Enrollment  ICMJE
 (submitted: February 4, 2012)
20
Actual Study Completion Date  ICMJE July 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01528592
Other Study ID Numbers  ICMJE Ruby-60029592
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Darren Gitelman, Northwestern University
Study Sponsor  ICMJE Northwestern University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Darren R Gitelman, MD Northwestern University
PRS Account Northwestern University
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP