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Clinical Trials/NCT01528592
NCT01528592
Completed
Not Applicable

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

Northwestern University1 site in 1 country18 target enrollmentJune 2011

Overview

Phase
Not Applicable
Intervention
Carbidopa-Levodopa
Conditions
Parkinson's Disease
Sponsor
Northwestern University
Enrollment
18
Locations
1
Primary Endpoint
Correlation Coefficient Between UPDRS III Score and Independent Components Analysis Network Strength in Left Parietal Cortex.
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2011
End Date
July 2012
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Darren Gitelman

Medical Doctor, Associate Professor of Neurology and Physiology

Northwestern University

Eligibility 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

Arms & Interventions

On / Off medication

Subjects undergo MRI scanning in the medication off state and 1 hour after receiving medications.

Intervention: Carbidopa-Levodopa

Outcomes

Primary Outcomes

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.

Study Sites (1)

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