Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Oregon Health and Science University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The ultimate goal of this proposal is to reduce dyskinesia in Parkinson's Disease (PD) patients. Dyskinesias are abnormal movements, often caused by the standard treatment for PD symptoms, levodopa. In this study, we will test if biochemical devices are equal to the clinical rating system in measuring dyskinesias.
Levodopa induced dyskinesia (LID) is a major problem associated with chronic use of levodopa (LD) for symptomatic treatment of Parkinson's disease (PD). LD remains our most potent therapy and nearly all PD patients will use it. A substantial portion of them will experience LID, with the impact ranging from non-interfering to severely disabling. The objective of this study is to develop reliable and sensitive objective measures of LID that will quantify muscular control and postural stability in subjects with dyskinesia.
While the "gold standard" of measuring LID is the subjective RS, we will determine if objective biochemical devices will equal the reliability and validity of CRS. We hypothesize that force plate technology quantifies postural sway movements best, and pinch-grip will best quantify muscle overflow force during voluntary movements.
We will compare two biomechanical devices and a traditional clinical rating scale (CRS). Once biomechanical instrument measures LID in the setting of voluntary muscle activity, the other acquires LID data related to postural sway.. A cross-section of LD-treated patients with and without clinically apparent dyskinesia will be used to assess the measures.
32 subjects will be invited to participate, 24 with PD and 8 age-matched controls (likely unaffected spouses) without neurologic disease. Of the PD patients 7 will have no clinically apparent dyskinesia, 7 will have mild dyskinesia and 7 with moderate to severe dyskinesia will be recruited (3 additional subjects are included to account for missing data or drop-outs).
They will comfortably stand with their feet placed in a preset marked stance on the force plate either with or without a mental task and pick up a pinch-grip device multiple times. Testing will be done in the effective motor "on" and "off" states to establish validity and reliability of instrument data, as these states often reflect the usual clinical experience of patients. The second method for rating dyskinesia will be the Clinical Rating Scale. Subjects will be rated while standing on the force plate during both mental task and non-mental task conditions.
All subjects will undergo this testing. Healthy subjects will undergo this testing three times during one visit. Subjects with PD will be admitted overnight, and have seven testing periods which will vary in the number of times the procedures will be done. Inpatient subjects will also receive 1mg/kg/hr or 1.5mg/kg/hr of intravenous levodopa depending on their everyday usage of levodopa or levodopa equivalent medications for 2 hours (9AM - 11AM) with carbidopa 25 mg po at 8AM, 10AM and noon to prevent nausea.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levodopa (delivered intravenously) | Drug | IV Levodopa is given from 09:00 to 11:00 am during the testing phase of the study. The IV Levodopa allows the researchers to watch one full "on" and "off" levodopa cycle while in the inpatient unit. |
| Measure | Description | Time Frame |
|---|---|---|
| Gaitmat Stance Measurements (AUC) | Gaitmat stance measurements were measured every half hour throughout an 8 hour period. Area under the curve was computed using the trapezoidal method for root mean squared velocity in the anterior-posterior direction. Each subject's unique baseline was used by computing the mean of the test-retest period measured at 08:00 am. | Every 1/2 hour during an 8 hour period. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Parkinson's disease patients on Levodopa with or without dyskinesia (abnormal involuntary movements caused by levodopa usage).
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kathryn Anne Chung, MD | VA Medical Center, Portland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Medical Center, Portland | Portland | Oregon | 97201 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Parkinson's Disease | Parkinson's disease with and without Levodopa-Induced Dyskinesia (no intervention). |
| FG001 | Controls | Non-Parkinson's Disease Controls (no intervention). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | PD - No LID | Parkinson's disease without levodopa-induced dyskinesia |
| BG001 | PD - Mild LID | Parkinson's disease with mild to moderate levodopa-induced dyskinesia (mAIMS <= 7) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Gaitmat Stance Measurements (AUC) | Gaitmat stance measurements were measured every half hour throughout an 8 hour period. Area under the curve was computed using the trapezoidal method for root mean squared velocity in the anterior-posterior direction. Each subject's unique baseline was used by computing the mean of the test-retest period measured at 08:00 am. | Posted | Mean | Standard Deviation | Root Mean Square of Velocity*Minutes | Every 1/2 hour during an 8 hour period. |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PD - No LID | Parkinson's disease without levodopa-induced dyskinesia |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kathryn Chung, MD | Portland VA Health Care System (PORVAHCS) | 503.220.8262 | 51091 | CHUNGKA@OHSU.EDU |
Not provided
| ID | Term |
|---|---|
| D020820 | Dyskinesias |
| D009069 | Movement Disorders |
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D007980 | Levodopa |
| ID | Term |
|---|---|
| D004295 | Dihydroxyphenylalanine |
| D002395 | Catecholamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
| BG002 | PD - Mod LID | Parkinson's disease with moderate to severe levodopa-induced dyskinesia (mAIMS > 8) |
| BG003 | Controls - No PD | Controls with no Parkinson's disease |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Duration of Disease (years) | Mean | Standard Deviation | years |
|
| UPDRS (part III) | Unified Parkinson's Disease Rating Scale - Part III (Motor Section). This scale rates from 0 (normal) to 4 (Can barely perform the task) several motor areas including speech, facial expression, tremor, rigidity, hand movements, agility, posture, and gait. Higher values on this scale represent a more severe stage of the disease. the total score ranges from 0 to 108, with higher scores representing a more sever stage of the disease. | Mean | Standard Deviation | units on a scale |
|
| mAIMS at Screening | Modified Abnormal Involuntary Movement Rating Scale (mAIMS). This is a commonly utilized scale that is completed by an observer who judges the severity of levodopa induced dyskinesia (LID) in 7 body parts (face, neck, trunk, both legs, and both arms) during the finger tapping task, and during the Get-Up and go task (both described below). All body parts are rated separately on this 0 (none) to 4 (severe - markedly impairs activities) scale. Thus, the total score can range from 0 - 28 with 28 indicating the most severe LID. | Mean | Standard Deviation | units on a scale |
|
| OG002 | PD - Mod LID | Parkinson's disease with moderate to severe levodopa-induced dyskinesia (mAIMS > 8) |
| OG003 | Controls - No PD | Controls with no Parkinson's disease |
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | PD - Mild LID | Parkinson's disease with mild to moderate levodopa-induced dyskinesia (mAIMS <= 7) | 0 | 11 | 0 | 11 |
| EG002 | PD - Mod LID | Parkinson's disease with moderate to severe levodopa-induced dyskinesia (mAIMS > 8) | 0 | 4 | 0 | 4 |
| EG003 | Controls - No PD | Controls with no Parkinson's disease | 0 | 6 | 0 | 6 |
Not provided
Not provided
Not provided
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D002396 |
| Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014443 | Tyrosine |