Tele-diagnostics for Remote Parkinson's Monitoring | NCT01356056

Studies
Tele-diagnostics for Remote Parkinson's Monitoring

NCT01356056

Sponsor

Great Lakes NeuroTechnologies Inc.

Status

Completed

Last Update Posted

Mar 12, 2013Estimated

Enrollment

12Actual

Phase

Not provided

Conditions

Parkinson's Disease

Interventions

Kinesia HomeView

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
7R43NS065554-03	U.S. NIH Grant/Contract		View source
5R43MD004049-02	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Mar 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2011

Primary Completion Date

Dec 2011Actual

Completion Date

Not provided

First Submitted Date

May 17, 2011

First Submission Date that Met QC Criteria

May 18, 2011

First Posted Date

May 19, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 11, 2013

Last Update Posted Date

Mar 12, 2013Estimated

Name	Class
University of Cincinnati	OTHER

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Kinesia HomeView Monitoring		Uses Kinesia HomeView at home once per week	Device: Kinesia HomeView
Control		Assessed in the clinic every 4 weeks using traditional methods

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Kinesia HomeView	Device	Quantifies motor symptom severity in the home	Kinesia HomeView Monitoring

Measure	Description	Time Frame
UPDRS		Every 4 weeks
PDQ-39		Every 4 weeks

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with Parkinson's disease

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Cincinnati		Cincinnati	Ohio	45267	United States

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided