Kinesia HomeView - Home Diary Comparison

Parkinson's Disease Clinical Trial

Official title:

Kinesia HomeView - Home Diary Comparison

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01920425
• Other study ID #: 1311DH
• Secondary ID: 1311DH
• Status: Completed
• Phase: N/A
• First received: August 7, 2013
• Last updated: January 8, 2016
• Start date: July 2013
• Est. completion date: September 2015

Study information

• Verified date: January 2016
• Source: Great Lakes NeuroTechnologies Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The objective is to compare the sensitivity and test-retest reliability of Kinesia HomeView to electronic and hand-written diaries for tracking medication state in the home. Demonstrating comparable or superior results will further support use of the Kinesia HomeView system as an outcome measure in clinical drug trials.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: September 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of Parkinson's disease

• On a stable antiparkinsonian medication regimen that includes levodopa for at least 4 weeks

• Experiencing dyskinesia more than 25% of the waking day (score = 2 on Unified Parkinson's Disease Rating Scale item 32)

• With dyskinesias at least moderately disabling (score = 2 on Unified Parkinson's Disease Rating Scale item 33)

• Capable of accurately completing diaries

• Capable of accurately using Kinesia HomeView

Exclusion Criteria:

• Significant medical or psychiatric illness

• Subjects not capable of following the required clinical instructions

• Serious medical conditions that would compromise safety

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Device:
• Kinesia HomeView
Motion sensor based telemedicine system for assessment of movement disorder motor symptoms in the home. Includes automated motor assessment using motion sensor and electronic dyskinesia diary.

Other:
• Hand-written diary
Hand-written paper diary indicating state (Off, On without dyskinesias, on with non-troublesome dyskinesias, on with troublesome dyskinesias) at 30 minute intervals.

Locations

Country	Name	City	State
United States	Great Lakes NeuroTechnologies Inc	Valley View	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Great Lakes NeuroTechnologies Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Test-retest reliability	Test-retest reliability will be compared between Kinesia HomeView measures, hand-written diary entries, and electronic diary entries.	4 weeks	No
Secondary	Kinesia HomeView usability questionnaire	Questionnaires on the usability of Kinesia HomeView will be completed following the 4-week data collection period.	After 4 weeks	No