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PharmacoMRI of Parkinson Disease

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Carbidopa-Levodopa
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Parkinson's Disease

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Northwestern University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

On / Off medication

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 31, 2012
Last Updated
April 2, 2018
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT01528592
Brief Title
PharmacoMRI of Parkinson Disease
Official Title
A Pilot Study of the Drug Effects on Brain Connectivity of Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
On / Off medication
Arm Type
Experimental
Arm Description
Subjects undergo MRI scanning in the medication off state and 1 hour after receiving medications.
Intervention Type
Drug
Intervention Name(s)
Carbidopa-Levodopa
Intervention Description
Equivalent amount of carbidopa-levodopa will be provide to you
Primary Outcome Measure Information:
Title
Correlation Coefficient Between UPDRS III Score and Independent Components Analysis Network Strength in Left Parietal Cortex.
Description
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.
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Darren R Gitelman, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

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PharmacoMRI of Parkinson Disease

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