Assessment of Tremor Using SNUMAP Motion Sensing System

This study is currently recruiting participants. (see Contacts and Locations)
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
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: 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 September 15, 2014