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Developing Objective Measures of Levodopa Induced Dyskinesia: (Study 1)
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Department of Veterans Affairs
Oregon Health and Science University
General Clinical Research Center (GCRC) at OHSU
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00467597
  Purpose

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 forPD symptoms, levodopa. In this study, we will test if biochemical devices are equal to the clinical rating system in measuring dyskinesias.


Condition Intervention
Dyskinesias
Movement Disorders
Parkinson Disease
Drug: Levodopa (delivered intravenously)

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease
MedlinePlus related topics: Movement Disorders Parkinson's Disease
Drug Information available for: Levodopa
U.S. FDA Resources
Study Type: Observational
Study Design: Case Control, Prospective
Official Title: Quantification of Levodopa Induced Dyskinesia in Parkinson Disease: Developing Objective Measures of Levodopa Induced Dyskinesia (Study One)

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Gaitmat Stance Measurements [ Time Frame: During the inpatient stay. ] [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: April 2006
Estimated Study Completion Date: April 2009
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00467597

Locations
United States, Oregon
VA Medical Center, Portland
Portland, Oregon, United States, 97201
Sponsors and Collaborators
Oregon Health and Science University
General Clinical Research Center (GCRC) at OHSU
Investigators
Principal Investigator: Kathryn Chung, MD VA Medical Center, Portland
  More Information

Publications of Results:
Responsible Party: Department of Veterans Affairs ( Chung, Kathryn - Principal Investigator )
Study ID Numbers: RCD-003-05F
Study First Received: April 27, 2007
Last Updated: October 1, 2008
ClinicalTrials.gov Identifier: NCT00467597  
Health Authority: United States: Federal Government;   United States: Food and Drug Administration

Keywords provided by Department of Veterans Affairs:
Dyskinesia
Levodopa
Movement Disorders
Parkinson Disease

Study placed in the following topic categories:
Levodopa
Ganglion Cysts
Basal Ganglia Diseases
Central Nervous System Diseases
Brain Diseases
Neurodegenerative Diseases
Dyskinesias
Signs and Symptoms
Dopamine
Parkinson Disease
Movement Disorders
Neurologic Manifestations
Parkinsonian Disorders

Additional relevant MeSH terms:
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases
Antiparkinson Agents
Dopamine Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009