Ambulatory Parkinson's Disease Dyskinesia Monitor for Drug Therapy Titration

Parkinson's Disease Clinical Trial

— Kinesia-D  

Official title:

Kinesia-D Phase II In-Clinic Continuous Assessment Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02125825
• Other study ID #: KinesiaDPhaseIIYear1
• Secondary ID: 9R44AG044293
• Status: Completed
• Phase: N/A
• First received: April 25, 2014
• Last updated: January 8, 2016
• Start date: July 2014
• Est. completion date: December 2014

Study information

• Verified date: January 2016
• Source: Great Lakes NeuroTechnologies Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Locations

Country	Name	City	State
United States	Johns Hopkins Medical Center	Baltimore	Maryland
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (4)

Lead Sponsor	Collaborator
Great Lakes NeuroTechnologies Inc.	Johns Hopkins University, National Institute on Aging (NIA), University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between motion sensor features and clinician-rated dyskinesia severity	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	No