PharmacoMRI of Parkinson Disease
A Pilot Study of the Drug Effects on Brain Connectivity of Parkinson's Disease
1 other identifier
interventional
18
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 31, 2012
CompletedFirst Posted
Study publicly available on registry
February 8, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedResults Posted
Study results publicly available
December 24, 2013
CompletedMay 3, 2018
April 1, 2018
1.1 years
January 31, 2012
November 6, 2013
April 2, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Correlation Coefficient Between UPDRS III Score and Independent Components Analysis Network Strength in Left Parietal Cortex.
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.
1 hour
Study Arms (1)
On / Off medication
EXPERIMENTALSubjects undergo MRI scanning in the medication off state and 1 hour after receiving medications.
Interventions
Equivalent amount of carbidopa-levodopa will be provide to you
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Northwestern University
Chicago, Illinois, 60611, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Darren Gitelman, MD
- Organization
- Northwestern University
Study Officials
- PRINCIPAL INVESTIGATOR
Darren R Gitelman, MD
Northwestern University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Doctor, Associate Professor of Neurology and Physiology
Study Record Dates
First Submitted
January 31, 2012
First Posted
February 8, 2012
Study Start
June 1, 2011
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
May 3, 2018
Results First Posted
December 24, 2013
Record last verified: 2018-04