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NCT01978080 Clinical Trial

Continuous Tremor Assessment During Daily Activities

Essential Tremor Clinical Trial

Official title:
ETSense: Adaptive Portable Essential Tremor Monitor - Symptomatic Impact Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01978080
Other study ID # 5R44AG034708-03
Secondary ID 5R44AG034708
Status Completed
Phase N/A
First received October 31, 2013
Last updated December 9, 2014
Start date October 2013

Study information
Verified date December 2014
Source Great Lakes NeuroTechnologies Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 39
Est. completion date
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Kinesia HomeView

Locations
Country Name City State
United States Rush University Medical Center Chicago Illinois
United States Baylor College of Medicine Houston Texas

Sponsors (4)
Lead Sponsor Collaborator
Great Lakes NeuroTechnologies Inc. Baylor College of Medicine, National Institute on Aging (NIA), Rush University Medical Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical Global Impression-Change Scale score Utilized to measure any improvement or worsening of symptoms relative to a baseline state at enrollment End of Month 1, End of Month 2, End of Month 3
Secondary Clinical Global Impression-Severity Scale Score Utilized to measure overall tremor severity Enrollment, End of Month 1, End of Month 2, End of Month 3
Secondary Washington Heights Inwood Genetic Study of Essential Tremor (WHIGET) Tremor Rating Scale Utilized to measure overall tremor severity Enrollment, End of Month 1, End of Month 2, End of Month 3
Secondary Quality of Life in Essential Tremor Questionnaire Utilized to measure the impact tremor has on overall quality of life Enrollment, End of Month 1, End of Month 2, End of Month 3
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