PharmacoMRI of Parkinson Disease

Not Applicable

Completed

• Conditions: Parkinson's Disease
• Interventions: Drug: Carbidopa-Levodopa

• Registration Number: NCT01528592
• Lead Sponsor: Northwestern University

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2012-01-31
• Study First Submitted QC: 2012-02-04
• Study First Posted: 2012-02-08
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Results First Submitted: 2013-11-06
• Results First Submitted QC: 2013-11-06
• Results First Posted: 2013-12-24
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-02
• Last Update Posted: 2018-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
On / Off medication	Carbidopa-Levodopa	Subjects undergo MRI scanning in the medication off state and 1 hour after receiving medications.

Primary Outcome Measures

Name	Time	Method
Correlation Coefficient Between UPDRS III Score and Independent Components Analysis Network Strength in Left Parietal Cortex.	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.

Trial Locations

Locations (1)

Northwestern University; 🇺🇸 Chicago, Illinois, United States