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Kinesia HomeView - Home Diary Comparison

G

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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