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Continuous Tremor Assessment During Daily Activities

NCT ID: NCT01978080

Last Updated: 2014-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Essential Tremor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Tremor reports provided

Kinesia HomeView utilized to monitor tremor at home and reports provided to treating clinician

Group Type EXPERIMENTAL

Kinesia HomeView

Intervention Type DEVICE

Tremor reports not provided

Kinesia HomeView utilized to monitor tremor at home and reports not provided to treating clinician

Group Type ACTIVE_COMPARATOR

Kinesia HomeView

Intervention Type DEVICE

Interventions

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Kinesia HomeView

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Cognitive limitations that prevent comprehension or execution of study protocol
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rush University Medical Center

OTHER

Sponsor Role collaborator

Baylor College of Medicine

OTHER

Sponsor Role collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Great Lakes NeuroTechnologies Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dustin Heldman, PhD

Role: PRINCIPAL_INVESTIGATOR

Great Lakes NeuroTechnologies

Locations

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Rush University Medical Center

Chicago, Illinois, United States

Site Status

Baylor College of Medicine

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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5R44AG034708

Identifier Type: NIH

Identifier Source: secondary_id

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5R44AG034708-03

Identifier Type: NIH

Identifier Source: org_study_id

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