Assessment of Tremor Using SNUMAP Motion Sensing System | NCT01731145

Studies
Assessment of Tremor Using SNUMAP Motion Sensing System

NCT01731145

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Jul 8, 2015Estimated

Enrollment

187Actual

Phase

Not Applicable

Conditions

Tremor

Interventions

SNUMAP

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2014

Primary Completion Date

Feb 2015Actual

Completion Date

Feb 2015Actual

First Submitted Date

Nov 15, 2012

First Submission Date that Met QC Criteria

Nov 20, 2012

First Posted Date

Nov 21, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 7, 2015

Last Update Posted Date

Jul 8, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

BS Jeon, Professor and Chairman, Department of Neurology, Seoul National University HospitalPrincipal Investigator

Lead Sponsor

Seoul National University HospitalOTHER

Collaborators

Name	Class
Life Science Technology Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

187Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SNUMAP assessment	Experimental	Uses SNUMAP motion sensing system to quantify tremor symptom.	Device: SNUMAP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SNUMAP	Device	Portable six-axis (tri-axial accelerometer and tri-axial gyroscope) motion sensing system	SNUMAP assessment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
3-D Accelerometric and gyroscope variables measured	Correlation between SNUMAP motion sensing system symptom assessment and clinical tremor rating scale (TRS) scores	1 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Beom S Jeon, M.D., Ph.D.	Seoul National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Neurology, Seoul National University Hospital		Seoul		110-744	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D014202	Tremor

Ancestor Terms

ID	Term
D020820	Dyskinesias
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided