Adaptive Portable Essential Tremor Monitor

This study has been completed.
Sponsor:
Collaborators:
Rush University Medical Center
Baylor College of Medicine
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
  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:


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

No publications provided

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 April 17, 2014