Kinesia HomeView - Home Diary Comparison

Great Lakes NeuroTechnologies

Status: Completed

Conditions: Parkinson's Disease

Treatments: Other: Hand-written diary; Device: Kinesia HomeView

Study type: Interventional

Funder types: Industry

Identifiers

NCT01920425

1311DH (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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2 participants in 2 patient groups

Hand-written diary first

Other group

Description:

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.

Treatment:

Device: Kinesia HomeView

Other: Hand-written diary

Kinesia HomeView first

Other group

Description:

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.

Treatment:

Device: Kinesia HomeView

Other: Hand-written diary