VibrationNCT01915342
Developing Optimal Focal Muscle Vibration for Improving Spasticity
A study testing Focal muscular vibration in people with Vibration and Electrophysiology, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The overall aim of the proposed study is to determine optimal parameter of focal muscle vibration for improving spasticity and identify neurophysiological mechanism in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vibration, Electrophysiology, Muscle Spasticity
- What is being tested?
- Focal muscular vibration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2013to Sep 2014
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteer
Who cannot join
- Unstable medical conditions
- History of epilepsy
- History of drug abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimization of Physical Focal Stimulation Parameters for Improving Spasticity and Identification of Neurophysiological Mechanism
The overall aim of the proposed study is to determine optimal parameter of focal muscle vibration for improving spasticity and identify neurophysiological mechanism in healthy subjects.
In investigation I-1, subjects will undergo focal muscle vibration with 40, 80, 120 Hz frequency at the medial gastrocnemius muscles (mGCM). As a surrogate maker of spasticity, H-reflex and compound motor action potential (CMAP) of the tibial nerve at mGCM will be recorded pre, during, and post vibration.
Read more
In investigation I-2, subjects will undergo focal muscle vibration with 0.1, 0.3, 0.5 mm amplitude at mGCM. H-reflex and CMAP of the tibial nerve at mGCM will be recorded pre, during, and post vibration.
In investigation II, subjects will undergo focal muscle vibration with predetermined parameters by the investigation I at mGCM. H-reflex and CMAP of the tibial nerve and motor evoked potential at mGCM will be recorded pre, during, and post vibration.
- Conditions
- Vibration, Electrophysiology, Muscle Spasticity
- Being tested
- Focal muscular vibration
- Keywords
- Monosynaptic reflex, H-reflex
- Medical subject headings
- Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focal muscular vibrationDevice
| Study group | Role | What they receive |
|---|---|---|
| Focal muscle vibration | Experimental | Focal muscular vibration will be applied at mGCM of each subject for 10 minutes in each session.
Frequency: 40, 80, 120 Hz Amplitude: 0.1, 0.3, 0.5 mm Receives: Device: Focal muscular vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
H/M ratio
The ratio of maximal H-reflex amplitude (mV) to CMAP amplitude (mV) recorded at mGCM
Measured: baseline, 1, 5 and 10 minutes during vibration, and 1 and 5 minutes after vibration
Secondary outcomes (6)
H amplitude
maximal H-reflex amplitude (mV) recorded at mGCM
Measured: baseline, 1, 5 and 10 minutes during vibration, and 1 and 5 minutes after vibration
M amplitude
CMAP amplitude (mV) recorded at mGCM
Measured: baseline, 1, 5 and 10 minutes during vibration, and 1 and 5 minutes after vibration
motor evoked potential (MEP) amplitude
Transcranial magnetic stimulation on the contralateral leg motor cortex is used to measure MEP at mGCM.
Measured: baseline, 10 minutes during vibration, and 5 minutes after vibration
Resting motor threshold (RMT)
Resting motor threshold (%) is defined as the minimal intensity of TMS capable of inducing MEPs greater than 100μV peak-to-peak amplitude in at least 3 of 5 trials.
Measured: baseline, 10 minutes during vibration, and 5 minutes after vibration
Short interval intracortical inhibition
Short interval intracortical inhibition is recorded by using conditioning stimulus of 90% RMT and test stimulus of 120% RMT with 1ms interval.
Measured: baseline, 10 minutes during vibration, and 5 minutes after vibration
Intracortical facilitation
Intracortical facilitation is recorded by using conditioning stimulus of 90% RMT and test stimulus of 120% RMT with 10ms interval.
Measured: baseline, 10 minutes during vibration, and 5 minutes after vibration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionMar 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VibrationStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Korea Institute of Science and Technology
- Responsible party
- Principal investigator, Byung-Mo Oh, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01915342
- Sponsor's protocol ID
- FMV07-2013-1010
- Status last verified
- Oct 2014
- First submitted
- 28 Jul 2013
- Last updated
- 10 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Physical Focal Stimulation Parameters for Improving Spasticity and Identification of Neurophysiological Mechanism
- ClinicalTrials.gov ID
- NCT01915342
- Acronym / sponsor ID
- FMV07-2013-1010
- Conditions
- Vibration, Electrophysiology, Muscle Spasticity
- Keywords
- Monosynaptic reflex, H-reflex
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Korea Institute of Science and Technology
- Study start
- Aug 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 2 Aug 2013 (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 overall aim of the proposed study is to determine optimal parameter of focal muscle vibration for improving spasticity and identify neurophysiological mechanism in healthy subjects.
In investigation I-1, subjects will undergo focal muscle vibration with 40, 80, 120 Hz frequency at the medial gastrocnemius muscles (mGCM). As a surrogate maker of spasticity, H-reflex and compound motor action potential (CMAP) of the tibial nerve at mGCM will be recorded pre, during, and post vibration.
In investigation I-2, subjects will undergo focal muscle vibration with 0.1, 0.3, 0.5 mm amplitude at mGCM. H-reflex and CMAP of the tibial nerve at mGCM will be recorded pre, during, and post vibration.
In investigation II, subjects will undergo focal muscle vibration with predetermined parameters by the investigation I at mGCM. H-reflex and CMAP of the tibial nerve and motor evoked potential at mGCM will be recorded pre, during, and post vibration.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Focal muscle vibration | Experimental | Device: Focal muscular vibrationFocal muscular vibration will be applied at mGCM of each subject for 10 minutes in each session. Frequency: 40, 80, 120 Hz Amplitude: 0.1, 0.3, 0.5 mm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy volunteer
Key exclusion criteria (3 listed)
- Unstable medical conditions
- History of epilepsy
- History of drug abuse
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 |
|---|---|---|
| Focal muscular vibration | Device | Focal muscle vibration |
Primary outcome
H/M ratio
Time frame: baseline, 1, 5 and 10 minutes during vibration, and 1 and 5 minutes after vibration
The ratio of maximal H-reflex amplitude (mV) to CMAP amplitude (mV) recorded at mGCM
6 secondary outcomes
H amplitude
Time frame: baseline, 1, 5 and 10 minutes during vibration, and 1 and 5 minutes after vibration
M amplitude
Time frame: baseline, 1, 5 and 10 minutes during vibration, and 1 and 5 minutes after vibration
motor evoked potential (MEP) amplitude
Time frame: baseline, 10 minutes during vibration, and 5 minutes after vibration
Resting motor threshold (RMT)
Time frame: baseline, 10 minutes during vibration, and 5 minutes after vibration
Short interval intracortical inhibition
Time frame: baseline, 10 minutes during vibration, and 5 minutes after vibration
Intracortical facilitation
Time frame: baseline, 10 minutes during vibration, and 5 minutes after vibration
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 10 Oct 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focal muscular vibration in people with Vibration and Electrophysiology, 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 1 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 10 Oct 2014. 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?
H/M ratio (time frame: baseline, 1, 5 and 10 minutes during vibration, and 1 and 5 minutes after vibration). 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 10 Oct 2014.