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Adaptive Portable Essential Tremor Monitor

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ClinicalTrials.gov Identifier: NCT01602042
Recruitment Status : Completed
First Posted : May 18, 2012
Last Update Posted : December 4, 2012
Sponsor:
Collaborators:
Rush University Medical Center
Baylor College of Medicine
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Great Lakes NeuroTechnologies Inc.

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease
Essential Tremor

Study Design
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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Phase II Study: Adaptive Portable Essential Tremor Monitor
Study Start Date : May 2012
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tremor
U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Tremor ratings during activities of daily living versus standardized tasks. [ Time Frame: 10 hours each day the sensor is worn. ]

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Great Lakes NeuroTechnologies Inc.
ClinicalTrials.gov Identifier: NCT01602042     History of Changes
Other Study ID Numbers: 2R44AG034708-02A1 ( U.S. NIH Grant/Contract )
First Posted: May 18, 2012    Key Record Dates
Last Update Posted: December 4, 2012
Last Verified: December 2012

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