Developing Optimal Focal Muscle Vibration for Improving Spasticity

Optimization of Physical Focal Stimulation Parameters for Improving Spasticity and Identification of Neurophysiological Mechanism

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01915342

Enrollment

Registered

2013-08-02

Start date

2013-08-31

Completion date

2014-09-30

Last updated

2014-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Electrophysiology, Muscle Spasticity, Vibration

Keywords

Monosynaptic reflex, H-reflex

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.

Interventions

DEVICEFocal muscular vibration

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Healthy volunteer

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
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.
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.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026