TremorSNUMAPNCT01731145
Assessment of Tremor Using SNUMAP Motion Sensing System
A study testing SNUMAP in people with Tremor, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Tremor
- What is being tested?
- SNUMAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 187 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2014to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 20-80 years
- Patients with tremor (involuntary, rhythmic, oscillatory movement in one or more body part)
- Subject who signed an informed consent
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Neurology, Seoul National University Hospital
Seoul, 110-744
About this study
Official title: Quantitative Assessment of Tremor Using Portable Six-axis (Tri-axial Accelerometer and Tri-axial Gyroscope) Motion Sensing System
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.
Read the 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.
- Conditions
- Tremor
- Being tested
- SNUMAP
- Keywords
- Tremor, SNUMAP, accelerometry, gyroscope, clinical rating scale
- Medical subject headings
- Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNUMAPDevice
Also called Hybrid (accelerometer and gyroscope)
Portable six-axis (tri-axial accelerometer and tri-axial gyroscope) motion sensing system
| Study group | Role | What they receive |
|---|---|---|
| SNUMAP assessment | Experimental | Uses SNUMAP motion sensing system to quantify tremor symptom. Receives: Device: SNUMAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-D Accelerometric and gyroscope variables measured
Correlation between SNUMAP motion sensing system symptom assessment and clinical tremor rating scale (TRS) scores
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2012 (estimated)
- Study startAug 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TremorStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Life Science Technology Inc.
- Responsible party
- Principal investigator, BS Jeon, Seoul National University Hospital
- Investigators
- Beom S Jeon, M.D., Ph.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01731145
- Sponsor's protocol ID
- D-1407-011-590
- Acronym
- SNUMAP
- Status last verified
- Jul 2015
- First submitted
- 15 Nov 2012
- Last updated
- 8 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Assessment of Tremor Using Portable Six-axis (Tri-axial Accelerometer and Tri-axial Gyroscope) Motion Sensing System
- ClinicalTrials.gov ID
- NCT01731145
- Acronym / sponsor ID
- SNUMAP / D-1407-011-590
- Conditions
- Tremor
- Keywords
- Tremor, SNUMAP, accelerometry, gyroscope, clinical rating scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Life Science Technology Inc.
- Study start
- Aug 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 21 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SNUMAP assessment | Experimental | Device: SNUMAPUses SNUMAP motion sensing system to quantify tremor symptom. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age: 20-80 years
- Patients with tremor (involuntary, rhythmic, oscillatory movement in one or more body part)
- Subject who signed an informed consent
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SNUMAPAlso: Hybrid (accelerometer and gyroscope)Portable six-axis (tri-axial accelerometer and tri-axial gyroscope) motion sensing system | Device | SNUMAP assessment |
Primary outcome
3-D Accelerometric and gyroscope variables measured
Time frame: 1 day
Correlation between SNUMAP motion sensing system symptom assessment and clinical tremor rating scale (TRS) scores
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beom S Jeon, M.D., Ph.D. principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SNUMAP in people with Tremor, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-D Accelerometric and gyroscope variables measured (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2015.