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Adaptive Portable Essential Tremor Monitor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date May 16, 2012
First Posted Date May 18, 2012
Last Update Posted Date December 4, 2012
Study Start Date May 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 3, 2012)
Tremor ratings during activities of daily living versus standardized tasks. [ Time Frame: 10 hours each day the sensor is worn. ]
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Adaptive Portable Essential Tremor Monitor
Official Title Phase II Study: Adaptive Portable Essential Tremor Monitor
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Essential tremor
Condition Essential Tremor
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 17, 2012)
20
Original Estimated Enrollment Same as current
Actual Study Completion Date November 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01602042
Other Study ID Numbers 2R44AG034708-02A1( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Great Lakes NeuroTechnologies Inc.
Original Responsible Party Same as current
Current Study Sponsor Great Lakes NeuroTechnologies Inc.
Original Study Sponsor Same as current
Collaborators
  • 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
PRS Account Great Lakes NeuroTechnologies Inc.
Verification Date December 2012