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Tele-diagnostics for Remote Parkinson's Monitoring

This study has been completed.
Sponsor:
Collaborator:
University of Cincinnati
Information provided by (Responsible Party):
Great Lakes NeuroTechnologies Inc.
ClinicalTrials.gov Identifier:
NCT01356056
First received: May 17, 2011
Last updated: March 11, 2013
Last verified: March 2013
History of Changes
  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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • UPDRS [ Time Frame: Every 4 weeks ] [ Designated as safety issue: No ]
  • PDQ-39 [ Time Frame: Every 4 weeks ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Great Lakes NeuroTechnologies Inc.
ClinicalTrials.gov Identifier: NCT01356056     History of Changes
Other Study ID Numbers: 10-09-29-03EE, 7R43NS065554-03, 5R43MD004049-02
Study First Received: May 17, 2011
Last Updated: March 11, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 16, 2013