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Tele-diagnostics for Remote Parkinson's Monitoring

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01356056
First Posted: May 19, 2011
Last Update Posted: March 12, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Cincinnati
Information provided by (Responsible Party):
Great Lakes NeuroTechnologies Inc.
  Purpose
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 Intervention
Parkinson's Disease Device: Kinesia HomeView

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Great Lakes NeuroTechnologies Inc.:

Primary Outcome Measures:
  • UPDRS [ Time Frame: Every 4 weeks ]
  • PDQ-39 [ Time Frame: Every 4 weeks ]

Enrollment: 12
Study Start Date: May 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Parkinson's disease
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01356056


Locations
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Sponsors and Collaborators
Great Lakes NeuroTechnologies Inc.
University of Cincinnati
  More Information

Responsible Party: Great Lakes NeuroTechnologies Inc.
ClinicalTrials.gov Identifier: NCT01356056     History of Changes
Other Study ID Numbers: 10-09-29-03EE
7R43NS065554-03 ( U.S. NIH Grant/Contract )
5R43MD004049-02 ( U.S. NIH Grant/Contract )
First Submitted: May 17, 2011
First Posted: May 19, 2011
Last Update Posted: March 12, 2013
Last Verified: March 2013

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases


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