Developing Optimal Focal Muscle Vibration for Improving Spasticity

October 8, 2014 updated by: Byung-Mo Oh, Seoul National University Hospital

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.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy volunteer

Exclusion Criteria:

  • Unstable medical conditions
  • History of epilepsy
  • History of drug abuse

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Focal muscle vibration

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
Device: Focal muscular vibration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline, 1, 5 and 10 minutes during vibration, and 1 and 5 minutes after vibration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
H amplitude
Time Frame: baseline, 1, 5 and 10 minutes during vibration, and 1 and 5 minutes after vibration
maximal H-reflex amplitude (mV) recorded at mGCM
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
CMAP amplitude (mV) recorded at mGCM
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
Transcranial magnetic stimulation on the contralateral leg motor cortex is used to measure MEP at mGCM.
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
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.
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
Short interval intracortical inhibition is recorded by using conditioning stimulus of 90% RMT and test stimulus of 120% RMT with 1ms interval.
baseline, 10 minutes during vibration, and 5 minutes after vibration
Intracortical facilitation
Time Frame: baseline, 10 minutes during vibration, and 5 minutes after vibration
Intracortical facilitation is recorded by using conditioning stimulus of 90% RMT and test stimulus of 120% RMT with 10ms interval.
baseline, 10 minutes during vibration, and 5 minutes after vibration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Korea Institute of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (ACTUAL)

March 1, 2014

Study Completion (ACTUAL)

September 1, 2014

Study Registration Dates

First Submitted

July 28, 2013

First Submitted That Met QC Criteria

July 31, 2013

First Posted (ESTIMATE)

August 2, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

October 10, 2014

Last Update Submitted That Met QC Criteria

October 8, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMV07-2013-1010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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