Continuous Tremor Assessment During Daily Activities

December 9, 2014 updated by: Great Lakes NeuroTechnologies Inc.

ETSense: Adaptive Portable Essential Tremor Monitor - Symptomatic Impact Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tremor reports provided
Kinesia HomeView utilized to monitor tremor at home and reports provided to treating clinician
Device: Kinesia HomeView
Active Comparator: Tremor reports not provided
Kinesia HomeView utilized to monitor tremor at home and reports not provided to treating clinician
Device: Kinesia HomeView

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
End of Month 1, End of Month 2, End of Month 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Global Impression-Severity Scale Score
Time Frame: Enrollment, End of Month 1, End of Month 2, End of Month 3
Utilized to measure overall tremor severity
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
Time Frame: Enrollment, End of Month 1, End of Month 2, End of Month 3
Utilized to measure overall tremor severity
Enrollment, End of Month 1, End of Month 2, End of Month 3
Quality of Life in Essential Tremor Questionnaire
Time Frame: 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
Enrollment, End of Month 1, End of Month 2, End of Month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Great Lakes NeuroTechnologies Inc.

Collaborators

Baylor College of Medicine
Rush University Medical Center
National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Dustin Heldman, PhD, Great Lakes NeuroTechnologies

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

October 31, 2013

First Submitted That Met QC Criteria

October 31, 2013

First Posted (Estimate)

November 7, 2013

Study Record Updates

Last Update Posted (Estimate)

December 10, 2014

Last Update Submitted That Met QC Criteria

December 9, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5R44AG034708-03 (U.S. NIH Grant/Contract)
  • 5R44AG034708 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Essential Tremor

Clinical Trials on Kinesia HomeView

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Equatorial Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe