PharmacoMRI of Parkinson Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Darren Gitelman, Northwestern University
ClinicalTrials.gov Identifier:
NCT01528592
First received: January 31, 2012
Last updated: November 6, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Parkinson's Disease
Drug: Carbidopa-Levodopa

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Pilot Study of the Drug Effects on Brain Connectivity of Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Efficacy of Parkinson's Medication on Brain Connectivity [ Time Frame: 2 and 1/2 hours ] [ Designated as safety issue: No ]
    Two 25-30 minute MRI scans will be conducted. The first when the patient is OFF PD medications for approximately 12 hours and the second following dosage of PD medication thereby being ON PD medication for the 25-30minute scan. There is an hour between the two scans that the patient will complete a series of cognitive assessments: UPDRS, MOCA, medical history, geriatric depression scale, and family history.

  • Correlation Coefficient Between UPDRS III Score and Independent Components Analysis Network Strength in Left Parietal Cortex. [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    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.


Enrollment: 18
Study Start Date: June 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: On / Off medication
Subjects undergo MRI scanning in the medication off state and 1 hour after receiving medications.
Drug: Carbidopa-Levodopa
Equivalent amount of carbidopa-levodopa will be provide to you

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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01528592

Locations
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Darren R Gitelman, MD Northwestern University
  More Information

No publications provided

Responsible Party: Darren Gitelman, Medical Doctor, Associate Professor of Neurology and Physiology, Northwestern University
ClinicalTrials.gov Identifier: NCT01528592     History of Changes
Other Study ID Numbers: Ruby-60029592
Study First Received: January 31, 2012
Results First Received: November 6, 2013
Last Updated: November 6, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Carbidopa
Levodopa
Carbidopa, levodopa drug combination
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Dopamine Agonists
Adjuvants, Immunologic
Immunologic Factors

ClinicalTrials.gov processed this record on July 22, 2014