Assessment of Tremor Using SNUMAP Motion Sensing System

Tremor Clinical Trial

— SNUMAP  

Official title:

Quantitative Assessment of Tremor Using Portable Six-axis (Tri-axial Accelerometer and Tri-axial Gyroscope) Motion Sensing System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01731145
• Other study ID #: D-1407-011-590
• Status: Completed
• Phase: N/A
• First received: November 15, 2012
• Last updated: July 7, 2015
• Start date: August 2014
• Est. completion date: February 2015

Study information

• Verified date: July 2015
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 187
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Tremor

Intervention

Device:
• SNUMAP
Portable six-axis (tri-axial accelerometer and tri-axial gyroscope) motion sensing system

Locations

Country	Name	City	State
Korea, Republic of	Department of Neurology, Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Life Science Technology Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-D Accelerometric and gyroscope variables measured	Correlation between SNUMAP motion sensing system symptom assessment and clinical tremor rating scale (TRS) scores	1 day	No