Assessment of Tremor Using SNUMAP Motion Sensing System

This study is currently recruiting participants.
Verified December 2013 by Seoul National University Hospital
Sponsor:
Collaborator:
Life Science Technology Inc. (Korea)
Information provided by (Responsible Party):
BS Jeon, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01731145
First received: November 15, 2012
Last updated: December 7, 2013
Last verified: December 2013
  Purpose

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 Intervention
Tremor
Device: SNUMAP

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • 3-D Accelerometric and gyroscope variables measured [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Correlation between SNUMAP motion sensing system symptom assessment and clinical tremor rating scale (TRS) scores


Estimated Enrollment: 187
Study Start Date: November 2012
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01731145

Contacts
Contact: Beom S Jeon, M.D., Ph.D. 82.2.2072.2876 ext 82.2 brain@snu.ac.kr

Locations
Korea, Republic of
Department of Neurology, Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Beom S Jeon, M.D., Ph.D.    +82 2 2072 2876    brain@snu.ac.kr   
Contact: Hui-Jun Yang, M.D.    +82 10 4340 1549    yanghuijun@cricmail.net   
Principal Investigator: Beom S Jeon, M.D., Ph.D.         
Sub-Investigator: Young Eun Kim, M.D.         
Sub-Investigator: Hui-Jun Yang, M.D.         
Sub-Investigator: Gwanhee Ehm, M.D.         
Sponsors and Collaborators
Seoul National University Hospital
Life Science Technology Inc. (Korea)
Investigators
Principal Investigator: Beom S Jeon, M.D., Ph.D. Seoul National University Hospital
  More Information

No publications provided

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: H-1202-078-398
Study First Received: November 15, 2012
Last Updated: December 7, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by 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

ClinicalTrials.gov processed this record on April 17, 2014