NCT02152319

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

May 27, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 2, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

April 28, 2016

Status Verified

April 1, 2016

Enrollment Period

1.8 years

First QC Date

May 27, 2014

Last Update Submit

April 26, 2016

Conditions

Parkinson's Disease

Keywords

Parkinson's diseaseTelemedicineTelehealthKinesiaTremorBradykinesiaDyskinesia

Outcome Measures

Primary Outcomes (1)

  • Percent of subjects completing remote assessments

    Percent of subjects who successfully completed the requested home-based Kinesia HomeView (KHV) automated motor assessments.

    7 Months

Secondary Outcomes (11)

  • Percent of remote assessments completed

    7 Months

  • KHV Motor Scores

    7 Months

  • KHV measured fluctuations

    7 Months

  • PDQ-39 responses

    7 Months

  • PACIC responses

    7 Months

  • +6 more secondary outcomes

Study Arms (2)

KHV reporting

EXPERIMENTAL

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

Device: KHV reportingProcedure: Standard care

Standard care

ACTIVE COMPARATOR

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.

Procedure: Standard care

Interventions

KHV reportingDEVICE

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

Also known as: Kinesia HomeView
KHV reporting
Standard carePROCEDURE

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

KHV reportingStandard care

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Parkinson DiseaseTremorHypokinesiaDyskinesias

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Joseph P Giuffrida, Ph.D.

    Great Lakes NeuroTechnologies

    PRINCIPAL INVESTIGATOR

  • Dustin A Heldman, Ph.D.

    Great Lakes NeuroTechnologies

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2014

First Posted

June 2, 2014

Study Start

May 1, 2014

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

April 28, 2016

Record last verified: 2016-04

Locations

US(1)