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Developing Optimal Focal Muscle Vibration for Improving Spasticity

Primary Purpose

Vibration, Electrophysiology, Muscle Spasticity

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Focal muscular vibration
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Vibration focused on measuring Monosynaptic reflex, H-reflex

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy volunteer

Exclusion Criteria:

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Focal muscle vibration

Arm Description

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

Outcomes

Primary Outcome Measures

H/M ratio
The ratio of maximal H-reflex amplitude (mV) to CMAP amplitude (mV) recorded at mGCM

Secondary Outcome Measures

H amplitude
maximal H-reflex amplitude (mV) recorded at mGCM
M amplitude
CMAP amplitude (mV) recorded at mGCM
motor evoked potential (MEP) amplitude
Transcranial magnetic stimulation on the contralateral leg motor cortex is used to measure MEP at mGCM.
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.
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.
Intracortical facilitation
Intracortical facilitation is recorded by using conditioning stimulus of 90% RMT and test stimulus of 120% RMT with 10ms interval.

Full Information

First Posted
July 28, 2013
Last Updated
October 8, 2014
Sponsor
Seoul National University Hospital
Collaborators
Korea Institute of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT01915342
Brief Title
Developing Optimal Focal Muscle Vibration for Improving Spasticity
Official Title
Optimization of Physical Focal Stimulation Parameters for Improving Spasticity and Identification of Neurophysiological Mechanism
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Korea Institute of Science and Technology

4. Oversight

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vibration, Electrophysiology, Muscle Spasticity
Keywords
Monosynaptic reflex, H-reflex

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Focal muscle vibration
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Focal muscular vibration
Primary Outcome Measure Information:
Title
H/M ratio
Description
The ratio of maximal H-reflex amplitude (mV) to CMAP amplitude (mV) recorded at mGCM
Time Frame
baseline, 1, 5 and 10 minutes during vibration, and 1 and 5 minutes after vibration
Secondary Outcome Measure Information:
Title
H amplitude
Description
maximal H-reflex amplitude (mV) recorded at mGCM
Time Frame
baseline, 1, 5 and 10 minutes during vibration, and 1 and 5 minutes after vibration
Title
M amplitude
Description
CMAP amplitude (mV) recorded at mGCM
Time Frame
baseline, 1, 5 and 10 minutes during vibration, and 1 and 5 minutes after vibration
Title
motor evoked potential (MEP) amplitude
Description
Transcranial magnetic stimulation on the contralateral leg motor cortex is used to measure MEP at mGCM.
Time Frame
baseline, 10 minutes during vibration, and 5 minutes after vibration
Title
Resting motor threshold (RMT)
Description
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.
Time Frame
baseline, 10 minutes during vibration, and 5 minutes after vibration
Title
Short interval intracortical inhibition
Description
Short interval intracortical inhibition is recorded by using conditioning stimulus of 90% RMT and test stimulus of 120% RMT with 1ms interval.
Time Frame
baseline, 10 minutes during vibration, and 5 minutes after vibration
Title
Intracortical facilitation
Description
Intracortical facilitation is recorded by using conditioning stimulus of 90% RMT and test stimulus of 120% RMT with 10ms interval.
Time Frame
baseline, 10 minutes during vibration, and 5 minutes after vibration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy volunteer Exclusion Criteria: Unstable medical conditions History of epilepsy History of drug abuse
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

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