Automated Telehealth Diagnostics for Remote Parkinson Monitoring

NCT ID: NCT02152319

Last Updated: 2016-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2016-02-29

Brief Summary

The objective is to clinically assess the Kinesia HomeView system for automated and remote monitoring of Parkinson's disease (PD) motor symptoms.

Detailed Description

Currently, there is limited access to movement disorder specialist centers for a significant portion of the PD population. Treatment effectiveness is judged during office visits by improvement of patient motor symptoms and quality of life. Clinicians evaluate patients by having them perform specific motor tasks and rating the severity on a 0-4 scale. A major limitation is that a single evaluation in a clinical setting may not accurately reflect motor symptom fluctuations experienced over the course of a day, week, or month. Clinicians currently lack effective, affordable medical devices that can be easily delivered to a patient's home for monitoring symptoms on a more continuous basis as motor symptoms typically change throughout the day. Kinesia HomeView provides a repeatable, automated system clinicians can use to remotely monitor PD motor symptoms on a more continuous basis in a patient's home. The investigators hypothesize use of the Kinesia HomeView system will improve outcomes and decrease costs especially for patient populations in areas not in close proximity to movement disorder specialists.

Conditions

Parkinson's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

KHV reporting

Clinicians will view the motor symptom severity reports and videoconference to titrate medications.

Group Type: EXPERIMENTAL

KHV reporting

Intervention Type: DEVICE

Clinicians will view the KHV motor symptom severity reports and use KHV to videoconference with subjects to titrate medications.

Standard care

Intervention Type: PROCEDURE

Subjects will receive the same disease management as if they were not participating in this study.

Standard care

Subjects in this group will still use KHV at home to minimize any placebo effects that could be attributed to using the system; however, clinicians will view the motor symptom severity reports and videoconference to titrate medications solely for the experimental subjects.

Group Type: ACTIVE_COMPARATOR

Standard care

Intervention Type: PROCEDURE

Subjects will receive the same disease management as if they were not participating in this study.

Interventions

KHV reporting

Clinicians will view the KHV motor symptom severity reports and use KHV to videoconference with subjects to titrate medications.

Intervention Type: DEVICE

Standard care

Subjects will receive the same disease management as if they were not participating in this study.

Intervention Type: PROCEDURE

Other Intervention Names

Kinesia HomeView

Eligibility Criteria

Inclusion Criteria

• Individuals with self-reported clinically-confirmed diagnosis of idiopathic Parkinson disease.
• Be fluent in English
• Willing and able to provide informed consent

Exclusion Criteria

• Inability to carry out study activities
• Subjects with cognitive deficits that would prevent following instructions and serious medical conditions that would compromise a subject's safety
• Subjects who have dementia, exhibited by those with a score less than 22 on the Montreal Cognitive Assessment (MoCA)
• Subjects with deep brain stimulation (DBS)

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Rochester

OTHER

Sponsor Role: collaborator

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

Great Lakes NeuroTechnologies Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joseph P Giuffrida, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Great Lakes NeuroTechnologies

Dustin A Heldman, Ph.D.

Role: STUDY_DIRECTOR

Great Lakes NeuroTechnologies

Locations

University of Rochester

Rochester, New York, United States

Countries

United States

Other Identifiers

5R44MD004049-05

Identifier Type: NIH

Identifier Source: secondary_id

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R44MD004049

Identifier Type: NIH

Identifier Source: org_study_id

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