Adaptive Portable Essential Tremor Monitor

December 3, 2012 updated by: Great Lakes NeuroTechnologies Inc.

Phase II Study: Adaptive Portable Essential Tremor Monitor

The purpose of this study is to evaluate the utility of a portable motion sensor-based system designed to monitor essential tremor (ET) to better prescribe therapy to minimize symptoms and expand care for ET patients.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

20

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Essential tremor

Description

Inclusion Criteria:

  • Aged 18 years or older
  • Clinical diagnosis of essential tremor
  • Able to provide informed consent

Exclusion Criteria:

  • Significant medical or psychiatric illness
  • Not capable of following the required clinical instructions
  • Serious medical conditions that compromise safety

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Tremor ratings during activities of daily living versus standardized tasks.
Time Frame: 10 hours each day the sensor is worn.
10 hours each day the sensor is worn.

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 A Heldman, PhD, CleveMed Inc. also dba 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

May 1, 2012

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

May 16, 2012

First Submitted That Met QC Criteria

May 17, 2012

First Posted (Estimate)

May 18, 2012

Study Record Updates

Last Update Posted (Estimate)

December 4, 2012

Last Update Submitted That Met QC Criteria

December 3, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2R44AG034708-02A1 (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.

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