Capturing Parkinson's Disease Medication Side Effects During Daily Activities

June 28, 2012 updated by: Great Lakes NeuroTechnologies Inc.

Phase I Study: Monitoring Levodopa-Induced Dyskinesia Using Accelerometer & Gyroscope-based Motion Detection System

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).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Idiopathic PD demonstrating levodopa-induced dyskinesias

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Great Lakes NeuroTechnologies Inc.

Collaborators

University of Rochester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Study Registration Dates

First Submitted

September 2, 2011

First Submitted That Met QC Criteria

September 6, 2011

First Posted (Estimate)

September 7, 2011

Study Record Updates

Last Update Posted (Estimate)

June 29, 2012

Last Update Submitted That Met QC Criteria

June 28, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R43NS071882-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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