Developing Optimal Focal Muscle Vibration for Improving Spasticity

Not Applicable

Completed

• Conditions: Vibration; Electrophysiology; Muscle Spasticity
• Interventions: Device: Focal muscular vibration

• Registration Number: NCT01915342
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-07-28
• Study First Submitted QC: 2013-07-31
• Study Start: 2013-08
• Study First Posted: 2013-08-02
• Primary Completion: 2014-03
• Study Completion: 2014-09
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-08
• Last Update Posted: 2014-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

• Healthy volunteer

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Focal muscle vibration	Focal muscular 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

Primary Outcome Measures

Name	Time	Method
H/M ratio	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

Secondary Outcome Measures

Name	Time	Method
M amplitude	baseline, 1, 5 and 10 minutes during vibration, and 1 and 5 minutes after vibration	CMAP amplitude (mV) recorded at mGCM
motor evoked potential (MEP) amplitude	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.
H amplitude	baseline, 1, 5 and 10 minutes during vibration, and 1 and 5 minutes after vibration	maximal H-reflex amplitude (mV) recorded at mGCM
Resting motor threshold (RMT)	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.
Short interval intracortical inhibition	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.
Intracortical facilitation	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.

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of