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Capturing Parkinson's Disease Medication Side Effects During Daily Activities

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01429207
First Posted: September 7, 2011
Last Update Posted: June 29, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Rochester
Information provided by (Responsible Party):
Great Lakes NeuroTechnologies Inc.
  Purpose
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
Parkinson's Disease Dyskinesia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Phase I Study: Monitoring Levodopa-Induced Dyskinesia Using Accelerometer & Gyroscope-based Motion Detection System

Resource links provided by NLM:


Further study details as provided by Great Lakes NeuroTechnologies Inc.:

Enrollment: 15
Study Start Date: August 2011
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 Submitted: September 2, 2011
First Posted: September 7, 2011
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