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Continuous Tremor Assessment During Daily Activities

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Rush University Medical Center
Baylor College of Medicine
Information provided by (Responsible Party):
Great Lakes NeuroTechnologies Inc.
ClinicalTrials.gov Identifier:
NCT01978080
First received: October 31, 2013
Last updated: September 5, 2014
Last verified: September 2014
  Purpose

The specific aim of this study is to evaluate if tremor severity and quality of life can be improved more using continuous home monitoring along with traditional assessments versus traditional assessments alone.


Condition Intervention
Essential Tremor
Device: Kinesia HomeView

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: ETSense: Adaptive Portable Essential Tremor Monitor - Symptomatic Impact Study

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Clinical Global Impression-Change Scale score [ Time Frame: End of Month 1, End of Month 2, End of Month 3 ] [ Designated as safety issue: No ]
    Utilized to measure any improvement or worsening of symptoms relative to a baseline state at enrollment


Secondary Outcome Measures:
  • Clinical Global Impression-Severity Scale Score [ Time Frame: Enrollment, End of Month 1, End of Month 2, End of Month 3 ] [ Designated as safety issue: No ]
    Utilized to measure overall tremor severity

  • Washington Heights Inwood Genetic Study of Essential Tremor (WHIGET) Tremor Rating Scale [ Time Frame: Enrollment, End of Month 1, End of Month 2, End of Month 3 ] [ Designated as safety issue: No ]
    Utilized to measure overall tremor severity

  • Quality of Life in Essential Tremor Questionnaire [ Time Frame: Enrollment, End of Month 1, End of Month 2, End of Month 3 ] [ Designated as safety issue: No ]
    Utilized to measure the impact tremor has on overall quality of life


Estimated Enrollment: 40
Study Start Date: October 2013
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tremor reports provided
Kinesia HomeView utilized to monitor tremor at home and reports provided to treating clinician
Device: Kinesia HomeView
Active Comparator: Tremor reports not provided
Kinesia HomeView utilized to monitor tremor at home and reports not provided to treating clinician
Device: Kinesia HomeView

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with essential tremor
  • Currently taking medication to control tremor

Exclusion Criteria:

  • Cognitive limitations that prevent comprehension or execution of study protocol
  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: NCT01978080

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 Heldman, PhD Great Lakes NeuroTechnologies
  More Information

No publications provided

Responsible Party: Great Lakes NeuroTechnologies Inc.
ClinicalTrials.gov Identifier: NCT01978080     History of Changes
Other Study ID Numbers: 5R44AG034708-03, 5R44AG034708
Study First Received: October 31, 2013
Last Updated: September 5, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Essential Tremor
Tremor
Central Nervous System Diseases
Dyskinesias
Movement Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on November 24, 2014