Kinesia HomeView - Home Diary Comparison

NCT01920425 | Completed

• 1 other identifier: 1311DH
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson's Disease

Keywords

Parkinson's disease; dyskinesia; fluctuations; tremor; bradykinesia; levodopa

Outcome Measures

Primary Outcomes (1)

• Test-retest reliability

  Test-retest reliability will be compared between Kinesia HomeView measures, hand-written diary entries, and electronic diary entries.

  4 weeks

Secondary Outcomes (1)

• Kinesia HomeView usability questionnaire

  After 4 weeks

Study Arms (2)

Hand-written diary first

OTHER

Participants in this group will use the hand-written diary for the first two week and switch to Kinesia HomeView and the electronic diary for the second two weeks.

Device: Kinesia HomeView; Other: Hand-written diary

Kinesia HomeView first

OTHER

Participants in this group will use Kinesia HomeView and the electronic diary for the first two week and switch to the hand-written diary for the second two weeks.

Device: Kinesia HomeView; Other: Hand-written diary

Interventions

Kinesia HomeView DEVICE

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.

Hand-written diary first; Kinesia HomeView first

Hand-written diary OTHER

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

Hand-written diary first; Kinesia HomeView first

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Significant medical or psychiatric illness
• Subjects not capable of following the required clinical instructions
• Serious medical conditions that would compromise safety

Sponsors & Collaborators

• Great Lakes NeuroTechnologies Inc.: lead

Study Sites (1)

Great Lakes NeuroTechnologies Inc

Valley View, Ohio, 44125, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Dyskinesias; Tremor; Hypokinesia

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dustin A Heldman, PhD

  Great Lakes NeuroTechnologies Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2013
• First Posted: August 12, 2013
• Study Start: July 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: September 1, 2015
• Last Updated: January 12, 2016

Record last verified: 2016-01

Locations

US (1)