Kinesia-D Phase II In-Clinic Continuous Assessment Study

Great Lakes NeuroTechnologies Inc.2 sites in 1 country14 target enrollmentJuly 2014

ConditionsParkinson's Disease

Overview

Phase: N/A
Intervention: Not specified
Conditions: Parkinson's Disease
Sponsor: Great Lakes NeuroTechnologies Inc.
Enrollment: 14
Locations: 2
Primary Endpoint: Correlation between motion sensor features and clinician-rated dyskinesia severity
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective is to assess a compact, portable, wireless movement disorder system with continuous monitoring capabilities to detect and quantify the severity of levodopa-induced dyskinesia in Parkinson's disease.

Registry

clinicaltrials.gov

Start Date

July 2014

End Date

December 2014

Last Updated

10 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Great Lakes NeuroTechnologies Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Diagnosis of idiopathic Parkinson's disease
•Clinical history of levodopa-induced dyskinesia
•21 Years of age or older
•Stage 2 - 4 OFF-medication on the Hoehn and Yahr scale

Exclusion Criteria

•Dementia (determined by a neuropsychological assessment)
•Severe tremor unaffected by levodopa

Outcomes

Primary Outcomes

Correlation between motion sensor features and clinician-rated dyskinesia severity

Time Frame: All data will be collected within a single session not to exceed 3 hours

Motor function (movement speed and magnitude measured with a motion sensor) will be collected for a period of 2 hours after taking normally prescribed dose of levodopa.