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OpenTrials
Completed

NCT Number: NCT01528592

PharmacoMRI of Parkinson Disease

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.

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Key information

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

carbidopa-levodopa

Drug

Equivalent amount of carbidopa-levodopa will be provide to you

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Feb 8, 2012
Registry last updated
May 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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