PharmacoMRI of Parkinson Disease

Parkinson's Disease Clinical Trial

Official title:

A Pilot Study of the Drug Effects on Brain Connectivity of Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01528592
• Other study ID #: Ruby-60029592
• Status: Completed
• Phase: N/A
• Start date: June 2011
• Est. completion date: July 2012

Study information

• Verified date: April 2018
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• Carbidopa-Levodopa
Equivalent amount of carbidopa-levodopa will be provide to you

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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