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Developing Objective Measures of Levodopa Induced Dyskinesia: (Study 1)

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ClinicalTrials.gov Identifier: NCT00467597
Recruitment Status : Completed
First Posted : April 30, 2007
Results First Posted : November 26, 2014
Last Update Posted : November 26, 2014
Sponsor:
Collaborator:
Oregon Health and Science University
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
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.

Condition or disease Intervention/treatment
Dyskinesias Movement Disorders Parkinson Disease Drug: Levodopa (delivered intravenously)

Detailed Description:

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.


Study Type : Observational
Actual Enrollment : 36 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Quantification of Levodopa Induced Dyskinesia in Parkinson Disease: Developing Objective Measures of Levodopa Induced Dyskinesia (Study One)
Study Start Date : April 2006
Actual Primary Completion Date : August 2008
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Levodopa
U.S. FDA Resources

Group/Cohort Intervention/treatment
Group 1 Drug: Levodopa (delivered intravenously)
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.



Primary Outcome Measures :
  1. Gaitmat Stance Measurements (AUC) [ Time Frame: Every 1/2 hour during an 8 hour period. ]
    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.



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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Parkinson's disease patients on Levodopa with or without dyskinesia (abnormal involuntary movements caused by levodopa usage).
Criteria

Inclusion Criteria:

  • Clinical diagnosis of probable idiopathic Parkinson's Disease or no neurologic disease (no disease for controls only)
  • At least 21 years of age
  • Mini Mental Status Exam Score>=25

Exclusion Criteria:

  • Evidence of psychosis (hallucinations or delusions) by history
  • Any unstable medical condition
  • Currently using dopamine blocking medication
  • Currently taking anticoagulants or MAO inhibitors

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00467597


Locations
United States, Oregon
VA Medical Center, Portland
Portland, Oregon, United States, 97201
Sponsors and Collaborators
VA Office of Research and Development
Oregon Health and Science University
Investigators
Principal Investigator: Kathryn Anne Chung, MD VA Medical Center, Portland

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00467597     History of Changes
Other Study ID Numbers: RCD-003-05F
First Posted: April 30, 2007    Key Record Dates
Results First Posted: November 26, 2014
Last Update Posted: November 26, 2014
Last Verified: November 2014

Keywords provided by VA Office of Research and Development:
Dyskinesia
Levodopa
Movement Disorders
Parkinson Disease

Additional relevant MeSH terms:
Parkinson Disease
Dyskinesias
Movement Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurologic Manifestations
Signs and Symptoms
Levodopa
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs