- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01356056
Tele-diagnostics for Remote Parkinson's Monitoring
March 11, 2013 updated by: Great Lakes NeuroTechnologies Inc.
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.
Study Overview
Study Type
Observational
Enrollment (Actual)
12
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
-
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Ohio
-
Cincinnati, Ohio, United States, 45267
- University of Cincinnati
-
-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with Parkinson's disease
Description
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 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
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Kinesia HomeView Monitoring
Uses Kinesia HomeView at home once per week
|
Quantifies motor symptom severity in the home
|
Control
Assessed in the clinic every 4 weeks using traditional methods
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
UPDRS
Time Frame: Every 4 weeks
|
Every 4 weeks
|
PDQ-39
Time Frame: Every 4 weeks
|
Every 4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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
May 1, 2011
Primary Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
May 17, 2011
First Submitted That Met QC Criteria
May 18, 2011
First Posted (Estimate)
May 19, 2011
Study Record Updates
Last Update Posted (Estimate)
March 12, 2013
Last Update Submitted That Met QC Criteria
March 11, 2013
Last Verified
March 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10-09-29-03EE
- 7R43NS065554-03 (U.S. NIH Grant/Contract)
- 5R43MD004049-02 (U.S. NIH Grant/Contract)
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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