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Capturing Parkinson's Disease Medication Side Effects During Daily Activities

This study has been completed.
Sponsor:
Collaborator:
University of Rochester
Information provided by (Responsible Party):
Great Lakes NeuroTechnologies Inc.
ClinicalTrials.gov Identifier:
NCT01429207
First received: September 2, 2011
Last updated: June 28, 2012
Last verified: June 2012
History of Changes
  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:

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

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

Enrollment: 15
Study Start Date: August 2011
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Great Lakes NeuroTechnologies Inc.
ClinicalTrials.gov Identifier: NCT01429207     History of Changes
Other Study ID Numbers: 1R43NS071882-01A1
Study First Received: September 2, 2011
Last Updated: June 28, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 22, 2013