Tele-diagnostics for Remote Parkinson's Monitoring

• Sponsor: Great Lakes NeuroTechnologies Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01356056
• Collaborator: University of Cincinnati (Other)
• Enrollment: 12
• Location: 1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson's Disease	Device: Kinesia HomeView

Study Design

• Study Type: Observational
• Actual Enrollment: 12 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Study Start Date: May 1, 2011
• Actual Primary Completion Date: Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Kinesia HomeView Monitoring Uses Kinesia HomeView at home once per week	Device: Kinesia HomeView; Quantifies motor symptom severity in the home
Control Assessed in the clinic every 4 weeks using traditional methods

Outcome Measures

Primary Outcome Measures

1. UPDRS [Every 4 weeks]

2. PDQ-39 [Every 4 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Cincinnati	Cincinnati	Ohio	United States	45267

Sponsors and Collaborators

• Great Lakes NeuroTechnologies Inc.
• University of Cincinnati

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Great Lakes NeuroTechnologies Inc.
• ClinicalTrials.gov Identifier: NCT01356056
• Other Study ID Numbers: 10-09-29-03EE; 7R43NS065554-03; 5R43MD004049-02
• First Posted: May 19, 2011
• Last Update Posted: Mar 12, 2013
• Last Verified: Mar 1, 2013

• Additional relevant MeSH terms: Parkinson Disease

Study Results

No Results Posted as of Mar 12, 2013