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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01915342
Other study ID # FMV07-2013-1010
Secondary ID
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


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
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