PharmacoMRI of Parkinson Disease

NCT ID: NCT01528592

Last Updated: 2018-05-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-07-31

Brief Summary

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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

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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.

Conditions

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Parkinson's Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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On / Off medication

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

Group Type EXPERIMENTAL

Carbidopa-Levodopa

Intervention Type DRUG

Equivalent amount of carbidopa-levodopa will be provide to you

Interventions

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Carbidopa-Levodopa

Equivalent amount of carbidopa-levodopa will be provide to you

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Darren Gitelman

Medical Doctor, Associate Professor of Neurology and Physiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Darren R Gitelman, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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Northwestern University

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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Ruby-60029592

Identifier Type: -

Identifier Source: org_study_id

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