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NCT01429207 Clinical Trial

Capturing Parkinson's Disease Medication Side Effects During Daily Activities

Parkinson's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01429207
Other study ID # 1R43NS071882-01A1
Secondary ID
Status Completed
Phase N/A
First received September 2, 2011
Last updated June 28, 2012
Start date August 2011

Study information
Verified date June 2012
Source Great Lakes NeuroTechnologies Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 15
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of Rochester Medical Center Rochester New York

Sponsors (2)
Lead Sponsor Collaborator
Great Lakes NeuroTechnologies Inc. University of Rochester

Country where clinical trial is conducted

United States, 

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