Tele-diagnostics for Remote Parkinson's Monitoring

Parkinson's Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01356056
• Other study ID #: 10-09-29-03EE
• Secondary ID: 7R43NS065554-035
• Status: Completed
• Phase: N/A
• First received: May 17, 2011
• Last updated: March 11, 2013
• Start date: May 2011

Study information

• Verified date: March 2013
• 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 this research study is to design, implement, and clinically assess a portable, user worn system for monitoring Parkinson's disease (PD) motor symptoms. The current standard in evaluating symptoms is the Unified Parkinson's Disease Rating Scale (UPDRS), a subjective, qualitative ranking system. The main goal of this research is to develop a quantitative system, Kinesia HomeView, to assess tremor as well as different features of bradykinesia in a home based system which can capture those symptom changes over the course of a day and aid in evaluating treatment protocol efficacy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of Parkinson's disease

Exclusion Criteria:

• Inability to follow the required clinical instruction

• Subjects with cognitive impairments that would prohibit them from properly using the Kinesia HomeView system

• Subjects without the cognitive ability to respond to researchers and let them know when any parameters of the study may become uncomfortable

• Subjects found on examination by our clinicians to have any physical limitations which would be counter productive to participation in this study.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Device:
• Kinesia HomeView
Quantifies motor symptom severity in the home

Locations

Country	Name	City	State
United States	University of Cincinnati	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Great Lakes NeuroTechnologies Inc.	University of Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	UPDRS		Every 4 weeks	No
Primary	PDQ-39		Every 4 weeks	No