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Prospective Evaluation of Forceplate Measured Levodopa-Induced Dyskinesia

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00912977
First received: June 2, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  Purpose

Nearly all Parkinson's disease (PD) patients eventually develop abnormal and unwanted movements (dyskinesias; LID) caused by the gold standard treatment, Levodopa. The severity of these movements can range from subtle to extremely debilitating and may or may not interfere with normal activities such as putting on a coat or brushing ones teeth. The purpose of this study is to demonstrate the validity and reliability of objectively measuring dyskinesia with a forceplate.


Condition
Parkinson's Disease

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Prospective Evaluation of Forceplate Measured Levodopa-Induced Dyskinesia

Resource links provided by NLM:

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

Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Forceplate Measure [ Time Frame: Every 1/2 hour ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Visual Rating Scale [ Time Frame: every 1/2 hour ] [ Designated as safety issue: No ]

Estimated Enrollment: 14
Study Start Date: June 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Group 1
Groups are defined by another study
Group 2
Groups are defined by another study
Group 3
Groups are defined by another study

Detailed Description:

The main outcome measure of this study are measurements taken every half hour during an inpatient study visit. These measurements include standing on a forceplate for 1 minute while performing a mental task such as reciting the alphabet backwards. During this forceplate stance, a rater will visually score your movements. All participants must be eligible for another Parkinson's disease study at Oregon Health and Science University.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Parkinsons disease patients with levodopa-induced dyskinesia

Criteria

Inclusion Criteria:

  • Parkinsons disease
  • Older than 18

Exclusion Criteria:

  • Must be participating in a Parkinsons disease study at Oregon Health & Science University
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00912977

Locations
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97201
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Kathryn Chung, MD Oregon Health and Science University
  More Information

Publications:

Responsible Party: Kathryn Chung, MD, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00912977     History of Changes
Other Study ID Numbers: e5348
Study First Received: June 2, 2009
Last Updated: June 2, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
Parkinsons disease
dyskinesia
measurement

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

ClinicalTrials.gov processed this record on May 16, 2013