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Assessment of Tremor Using SNUMAP Motion Sensing System (SNUMAP)

Primary Purpose

Tremor

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
SNUMAP
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Tremor focused on measuring Tremor, SNUMAP, accelerometry, gyroscope, clinical rating scale

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Neurology, Seoul National University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SNUMAP assessment

Arm Description

Uses SNUMAP motion sensing system to quantify tremor symptom.

Outcomes

Primary Outcome Measures

3-D Accelerometric and gyroscope variables measured
Correlation between SNUMAP motion sensing system symptom assessment and clinical tremor rating scale (TRS) scores

Secondary Outcome Measures

Full Information

First Posted
November 15, 2012
Last Updated
July 7, 2015
Sponsor
Seoul National University Hospital
Collaborators
Life Science Technology Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01731145
Brief Title
Assessment of Tremor Using SNUMAP Motion Sensing System
Acronym
SNUMAP
Official Title
Quantitative Assessment of Tremor Using Portable Six-axis (Tri-axial Accelerometer and Tri-axial Gyroscope) Motion Sensing System
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Life Science Technology Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tremor
Keywords
Tremor, SNUMAP, accelerometry, gyroscope, clinical rating scale

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
187 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SNUMAP assessment
Arm Type
Experimental
Arm Description
Uses SNUMAP motion sensing system to quantify tremor symptom.
Intervention Type
Device
Intervention Name(s)
SNUMAP
Other Intervention Name(s)
Hybrid (accelerometer and gyroscope)
Intervention Description
Portable six-axis (tri-axial accelerometer and tri-axial gyroscope) motion sensing system
Primary Outcome Measure Information:
Title
3-D Accelerometric and gyroscope variables measured
Description
Correlation between SNUMAP motion sensing system symptom assessment and clinical tremor rating scale (TRS) scores
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beom S Jeon, M.D., Ph.D.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neurology, Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

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Assessment of Tremor Using SNUMAP Motion Sensing System

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