Continuous Tremor Assessment During Daily Activities

Not Applicable

Completed

• Conditions: Essential Tremor
• Interventions: Device: Kinesia HomeView

• Registration Number: NCT01978080
• Lead Sponsor: Great Lakes NeuroTechnologies Inc.

Brief Summary

The specific aim of this study is to evaluate if tremor severity and quality of life can be improved more using continuous home monitoring along with traditional assessments versus traditional assessments alone.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-31
• Study First Submitted QC: 2013-10-31
• Study First Posted: 2013-11-07
• Status Verified: 2014-12
• Primary Completion: 2014-12
• Last Update Submitted: 2014-12-09
• Last Update Posted: 2014-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

• Diagnosed with essential tremor
• Currently taking medication to control tremor

Exclusion Criteria

• Cognitive limitations that prevent comprehension or execution of study protocol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tremor reports provided	Kinesia HomeView	Kinesia HomeView utilized to monitor tremor at home and reports provided to treating clinician
Tremor reports not provided	Kinesia HomeView	Kinesia HomeView utilized to monitor tremor at home and reports not provided to treating clinician

Primary Outcome Measures

Name	Time	Method
Clinical Global Impression-Change Scale score	End of Month 1, End of Month 2, End of Month 3	Utilized to measure any improvement or worsening of symptoms relative to a baseline state at enrollment

Secondary Outcome Measures

Name	Time	Method
Clinical Global Impression-Severity Scale Score	Enrollment, End of Month 1, End of Month 2, End of Month 3	Utilized to measure overall tremor severity
Washington Heights Inwood Genetic Study of Essential Tremor (WHIGET) Tremor Rating Scale	Enrollment, End of Month 1, End of Month 2, End of Month 3	Utilized to measure overall tremor severity
Quality of Life in Essential Tremor Questionnaire	Enrollment, End of Month 1, End of Month 2, End of Month 3	Utilized to measure the impact tremor has on overall quality of life

Trial Locations

Locations (2)

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States