Parkinson's Disease
Conditions
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.
Interventions
Equivalent amount of carbidopa-levodopa will be provide to you
Sponsors
Northwestern University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation Coefficient Between UPDRS III Score and Independent Components Analysis Network Strength in Left Parietal Cortex. | 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment period: 12/1/2011 - 4/30/2012 Location: Medical clinic in Chicago
Participants by arm
| Arm | Count |
|---|---|
| On / Off Medication Subjects undergo MRI scanning in the medication off state and 1 hour after receiving medications. | 18 |
| Total | 18 |
Baseline characteristics
| Characteristic | On / Off Medication |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 7 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants |
| Age, Continuous | 66.22 years STANDARD_DEVIATION 8.71 |
| Region of Enrollment United States | 18 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 18 |
| serious Total, serious adverse events | 0 / 18 |
Outcome results
Primary
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.
Time frame: 1 hour
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| On / Off Medication | Correlation Coefficient Between UPDRS III Score and Independent Components Analysis Network Strength in Left Parietal Cortex. | 0.5869 unitless |