Developing Optimal Focal Muscle Vibration for Improving Spasticity

Muscle Spasticity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01915342
• Other study ID #: FMV07-2013-1010
• Status: Completed
• Phase: N/A
• First received: July 28, 2013
• Last updated: October 8, 2014
• Start date: August 2013
• Est. completion date: September 2014

Study information

• Verified date: October 2014
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: September 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Healthy volunteer

Exclusion Criteria:

• Unstable medical conditions

• History of epilepsy

• History of drug abuse

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Electrophysiology
• Muscle Spasticity
• Vibration

Intervention

Device:
• Focal muscular vibration

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Korea Institute of Science and Technology

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	H/M ratio	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	No
Secondary	H amplitude	maximal H-reflex amplitude (mV) recorded at mGCM	baseline, 1, 5 and 10 minutes during vibration, and 1 and 5 minutes after vibration	No
Secondary	M amplitude	CMAP amplitude (mV) recorded at mGCM	baseline, 1, 5 and 10 minutes during vibration, and 1 and 5 minutes after vibration	No
Secondary	motor evoked potential (MEP) amplitude	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	No
Secondary	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.	baseline, 10 minutes during vibration, and 5 minutes after vibration	No
Secondary	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.	baseline, 10 minutes during vibration, and 5 minutes after vibration	No
Secondary	Intracortical facilitation	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	No