Adaptive Portable Essential Tremor Monitor

This study has been completed.

Sponsor:

Collaborators:

Rush University Medical Center

Baylor College of Medicine

National Institute on Aging (NIA)

Information provided by (Responsible Party):

Great Lakes NeuroTechnologies Inc.

ClinicalTrials.gov Identifier:

NCT01602042

First received: May 16, 2012

Last updated: December 3, 2012

Last verified: December 2012

History of Changes

Purpose

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.

Condition
Essential Tremor


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Phase II Study: Adaptive Portable Essential Tremor Monitor

Resource links provided by NLM:

Genetics Home Reference related topics: essential tremor

MedlinePlus related topics: Tremor

U.S. FDA Resources

Further study details as provided by Great Lakes NeuroTechnologies Inc.:

Primary Outcome Measures:

Tremor ratings during activities of daily living versus standardized tasks. [ Time Frame: 10 hours each day the sensor is worn. ] [ Designated as safety issue: No ]


Enrollment:	20
Study Start Date:	May 2012
Study Completion Date:	November 2012
Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Essential tremor

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01602042

Locations


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

Sponsors and Collaborators

Great Lakes NeuroTechnologies Inc.

Rush University Medical Center

Baylor College of Medicine

National Institute on Aging (NIA)

Investigators


Principal Investigator:	Dustin A Heldman, PhD	CleveMed Inc. also dba Great Lakes NeuroTechnologies

More Information


Responsible Party:	Great Lakes NeuroTechnologies Inc.
ClinicalTrials.gov Identifier:	NCT01602042 History of Changes
Other Study ID Numbers:	2R44AG034708-02A1
Study First Received:	May 16, 2012
Last Updated:	December 3, 2012
Health Authority:	United States: Institutional Review Board United States: Federal Government

Keywords provided by Great Lakes NeuroTechnologies Inc.:


essential tremor motion sensors tremor

Additional relevant MeSH terms:


Tremor Essential Tremor Dyskinesias Neurologic Manifestations	Nervous System Diseases Signs and Symptoms Movement Disorders Central Nervous System Diseases

ClinicalTrials.gov processed this record on September 28, 2016

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