Ambulatory Parkinson's Disease Dyskinesia Monitor for Drug Therapy Titration (Kinesia-D)

January 8, 2016 updated by: Great Lakes NeuroTechnologies Inc.

Kinesia-D Phase II In-Clinic Continuous Assessment Study

The objective is to assess a compact, portable, wireless movement disorder system with continuous monitoring capabilities to detect and quantify the severity of levodopa-induced dyskinesia in Parkinson's disease.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

14

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
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Medical Center
    • 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

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Individuals with Parkinson's disease and a history of levodopa-induced dyskinesia

Description

Inclusion Criteria:

  • Diagnosis of idiopathic Parkinson's disease
  • Clinical history of levodopa-induced dyskinesia
  • 21 Years of age or older
  • Stage 2 - 4 OFF-medication on the Hoehn and Yahr scale

Exclusion Criteria:

  • Dementia (determined by a neuropsychological assessment)
  • Severe tremor unaffected by levodopa

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

Cohorts and Interventions

Group / Cohort
Parkinson's disease on levodopa
Individuals with Parkinson's disease who are taking levodopa to treat motor symptoms

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between motion sensor features and clinician-rated dyskinesia severity
Time Frame: All data will be collected within a single session not to exceed 3 hours
Motor function (movement speed and magnitude measured with a motion sensor) will be collected for a period of 2 hours after taking normally prescribed dose of levodopa.
All data will be collected within a single session not to exceed 3 hours

Collaborators and Investigators

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

Sponsor

Great Lakes NeuroTechnologies Inc.

Collaborators

Johns Hopkins University
National Institute on Aging (NIA)
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

July 1, 2014

Primary Completion (ACTUAL)

December 1, 2014

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

April 25, 2014

First Submitted That Met QC Criteria

April 25, 2014

First Posted (ESTIMATE)

April 29, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

January 12, 2016

Last Update Submitted That Met QC Criteria

January 8, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KinesiaDPhaseIIYear1
  • 9R44AG044293 (NIH)

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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