ETSense: Adaptive Portable Essential Tremor Monitor - Symptomatic Impact Study

Great Lakes NeuroTechnologies Inc.2 sites in 1 country39 target enrollmentOctober 2013

ConditionsEssential Tremor

Overview

Phase: N/A
Intervention: Not specified
Conditions: Essential Tremor
Sponsor: Great Lakes NeuroTechnologies Inc.
Enrollment: 39
Locations: 2
Primary Endpoint: Clinical Global Impression-Change Scale score
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2013

End Date

December 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Great Lakes NeuroTechnologies Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

•Cognitive limitations that prevent comprehension or execution of study protocol

Outcomes

Primary Outcomes

Clinical Global Impression-Change Scale score

Time Frame: 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 Outcomes

Clinical Global Impression-Severity Scale Score(Enrollment, End of Month 1, End of Month 2, End of Month 3)
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)
Quality of Life in Essential Tremor Questionnaire(Enrollment, End of Month 1, End of Month 2, End of Month 3)