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Assessment of Tremor Using SNUMAP Motion Sensing System (SNUMAP)

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ClinicalTrials.gov Identifier: NCT01731145
Recruitment Status : Completed
First Posted : November 21, 2012
Last Update Posted : July 8, 2015
Sponsor:
Collaborator:
Life Science Technology Inc.
Information provided by (Responsible Party):
BS Jeon, Seoul National University Hospital

Brief Summary:
The purpose of this study is to record and measure tremor using portable six-axis (tri-axial accelerometer and tri-axial gyroscope) motion sensing system.

Condition or disease Intervention/treatment Phase
Tremor Device: SNUMAP Not Applicable

Detailed Description:
SNUMAP system is portable, finger-worn, battery powered device that contains MEMS (micro-electro-mechanical system) hybrid motion sensor (three-axis accelerometer and three-axis gyroscope). The SNUMAP device consists of a wrist module and finger module, which attaches to an patients's finger and transmits three dimensional motions to a wrist module for storage and further analysis. The aims of this study is to assess tremor severity using tri-axial accelerometry and gyroscope to determine the reliability and the correlation with clinical measurements.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 187 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Quantitative Assessment of Tremor Using Portable Six-axis (Tri-axial Accelerometer and Tri-axial Gyroscope) Motion Sensing System
Study Start Date : August 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tremor
U.S. FDA Resources

Arm Intervention/treatment
Experimental: SNUMAP assessment
Uses SNUMAP motion sensing system to quantify tremor symptom.
Device: SNUMAP
Portable six-axis (tri-axial accelerometer and tri-axial gyroscope) motion sensing system
Other Name: Hybrid (accelerometer and gyroscope)



Primary Outcome Measures :
  1. 3-D Accelerometric and gyroscope variables measured [ Time Frame: 1 day ]
    Correlation between SNUMAP motion sensing system symptom assessment and clinical tremor rating scale (TRS) scores



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age: 20-80 years
  • Patients with tremor (involuntary, rhythmic, oscillatory movement in one or more body part)
  • Subject who signed an informed consent

Exclusion Criteria:

  • Pregnant or nursing woman.
  • Comorbid neurologic illnesses that impact the ability to perform the study tasks.
  • Subjects with medical condition that in the opinion of the investigator would affect his/her ability to participate in this study.

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): NCT01731145


Locations
Korea, Republic of
Department of Neurology, Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Life Science Technology Inc.
Investigators
Principal Investigator: Beom S Jeon, M.D., Ph.D. Seoul National University Hospital

Responsible Party: BS Jeon, Professor and Chairman, Department of Neurology, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01731145     History of Changes
Other Study ID Numbers: D-1407-011-590
First Posted: November 21, 2012    Key Record Dates
Last Update Posted: July 8, 2015
Last Verified: July 2015

Keywords provided by BS Jeon, Seoul National University Hospital:
Tremor
SNUMAP
accelerometry
gyroscope
clinical rating scale

Additional relevant MeSH terms:
Tremor
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms