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Capturing Parkinson's Disease Medication Side Effects During Daily Activities

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ClinicalTrials.gov Identifier: NCT01429207
Recruitment Status : Completed
First Posted : September 7, 2011
Last Update Posted : June 29, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of the study is to test whether body-worn wireless motion sensors can measure dyskinesias (involuntary movements caused by medications) in individuals with Parkinson disease (PD) independent of voluntary activity being performed and other PD motor symptoms (e.g. tremor).

Condition or disease
Parkinson's Disease Dyskinesia

Study Design

Study Type : Observational
Actual Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Phase I Study: Monitoring Levodopa-Induced Dyskinesia Using Accelerometer & Gyroscope-based Motion Detection System
Study Start Date : August 2011

Resource links provided by the National Library of Medicine

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

Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Idiopathic PD demonstrating levodopa-induced dyskinesias
Criteria

Inclusion Criteria:

  • Clinical diagnosis of probable or definite idiopathic Parkinson Disease with motor fluctuations that include dyskinesias after taking their usual dose of levodopa/carbidopa

Exclusion Criteria:

  • Antipsychotic medications (including quetiapine and clozapine)
  • Coexisting neurologic disease such as stroke or dementia
  • Lacking capacity for informed consent
  • Residing in a nursing home
  • comorbid non-neurologic illnesses that impacts the ability to perform the study tasks
  • Implantable defibrillators
Contacts and Locations

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): NCT01429207


Locations
United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
Great Lakes NeuroTechnologies Inc.
University of Rochester
More Information

Responsible Party: Great Lakes NeuroTechnologies Inc.
ClinicalTrials.gov Identifier: NCT01429207     History of Changes
Other Study ID Numbers: 1R43NS071882-01A1 ( U.S. NIH Grant/Contract )
First Posted: September 7, 2011    Key Record Dates
Last Update Posted: June 29, 2012
Last Verified: June 2012

Keywords provided by Great Lakes NeuroTechnologies Inc.:
levodopa
tremor
bradykinesia
motion sensors

Additional relevant MeSH terms:
Parkinson Disease
Dyskinesias
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
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