NCT01731145

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
187

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 21, 2012

Completed
1.7 years until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

July 8, 2015

Status Verified

July 1, 2015

Enrollment Period

6 months

First QC Date

November 15, 2012

Last Update Submit

July 7, 2015

Conditions

Tremor

Keywords

TremorSNUMAPaccelerometrygyroscopeclinical rating scale

Outcome Measures

Primary Outcomes (1)

  • 3-D Accelerometric and gyroscope variables measured

    Correlation between SNUMAP motion sensing system symptom assessment and clinical tremor rating scale (TRS) scores

    1 day

Study Arms (1)

SNUMAP assessment

EXPERIMENTAL

Uses SNUMAP motion sensing system to quantify tremor symptom.

Device: SNUMAP

Interventions

SNUMAPDEVICE

Portable six-axis (tri-axial accelerometer and tri-axial gyroscope) motion sensing system

Also known as: Hybrid (accelerometer and gyroscope)
SNUMAP assessment

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 20-80 years
  • Patients with tremor (involuntary, rhythmic, oscillatory movement in one or more body part)
  • Subject who signed an informed consent

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology, Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Tremor

Condition Hierarchy (Ancestors)

DyskinesiasNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Beom S Jeon, M.D., Ph.D.

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Chairman, Department of Neurology

Study Record Dates

First Submitted

November 15, 2012

First Posted

November 21, 2012

Study Start

August 1, 2014

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

July 8, 2015

Record last verified: 2015-07

Locations

KR(1)