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Continuous Tremor Assessment During Daily Activities

Primary Purpose

Essential Tremor

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Kinesia HomeView

About this trial

This is an interventional diagnostic trial for Essential Tremor

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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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