Continuous Tremor Assessment During Daily Activities
Primary Purpose
Essential Tremor
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Kinesia HomeView
Sponsored by
About this trial
This is an interventional diagnostic trial for Essential Tremor
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
Sites / Locations
- Rush University Medical Center
- Baylor College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Tremor reports provided
Tremor reports not provided
Arm Description
Kinesia HomeView utilized to monitor tremor at home and reports provided to treating clinician
Kinesia HomeView utilized to monitor tremor at home and reports not provided to treating clinician
Outcomes
Primary Outcome Measures
Clinical Global Impression-Change Scale score
Utilized to measure any improvement or worsening of symptoms relative to a baseline state at enrollment
Secondary Outcome Measures
Clinical Global Impression-Severity Scale Score
Utilized to measure overall tremor severity
Washington Heights Inwood Genetic Study of Essential Tremor (WHIGET) Tremor Rating Scale
Utilized to measure overall tremor severity
Quality of Life in Essential Tremor Questionnaire
Utilized to measure the impact tremor has on overall quality of life
Full Information
NCT ID
NCT01978080
First Posted
October 31, 2013
Last Updated
December 9, 2014
Sponsor
Great Lakes NeuroTechnologies Inc.
Collaborators
Rush University Medical Center, Baylor College of Medicine, National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT01978080
Brief Title
Continuous Tremor Assessment During Daily Activities
Official Title
ETSense: Adaptive Portable Essential Tremor Monitor - Symptomatic Impact Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Great Lakes NeuroTechnologies Inc.
Collaborators
Rush University Medical Center, Baylor College of Medicine, National Institute on Aging (NIA)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Tremor
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tremor reports provided
Arm Type
Experimental
Arm Description
Kinesia HomeView utilized to monitor tremor at home and reports provided to treating clinician
Arm Title
Tremor reports not provided
Arm Type
Active Comparator
Arm Description
Kinesia HomeView utilized to monitor tremor at home and reports not provided to treating clinician
Intervention Type
Device
Intervention Name(s)
Kinesia HomeView
Primary Outcome Measure Information:
Title
Clinical Global Impression-Change Scale score
Description
Utilized to measure any improvement or worsening of symptoms relative to a baseline state at enrollment
Time Frame
End of Month 1, End of Month 2, End of Month 3
Secondary Outcome Measure Information:
Title
Clinical Global Impression-Severity Scale Score
Description
Utilized to measure overall tremor severity
Time Frame
Enrollment, End of Month 1, End of Month 2, End of Month 3
Title
Washington Heights Inwood Genetic Study of Essential Tremor (WHIGET) Tremor Rating Scale
Description
Utilized to measure overall tremor severity
Time Frame
Enrollment, End of Month 1, End of Month 2, End of Month 3
Title
Quality of Life in Essential Tremor Questionnaire
Description
Utilized to measure the impact tremor has on overall quality of life
Time Frame
Enrollment, End of Month 1, End of Month 2, End of Month 3
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dustin Heldman, PhD
Organizational Affiliation
Great Lakes NeuroTechnologies
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
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Continuous Tremor Assessment During Daily Activities
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