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Developing Optimal Focal Muscle Vibration for Improving Spasticity

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ClinicalTrials.gov Identifier: NCT01915342
Recruitment Status : Completed
First Posted : August 2, 2013
Last Update Posted : October 10, 2014
Sponsor:
Collaborator:
Korea Institute of Science and Technology
Information provided by (Responsible Party):
Byung-Mo Oh, Seoul National University Hospital

July 28, 2013
August 2, 2013
October 10, 2014
August 2013
March 2014   (Final data collection date for primary outcome measure)
H/M ratio [ Time Frame: 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
Same as current
Complete list of historical versions of study NCT01915342 on ClinicalTrials.gov Archive Site
  • H amplitude [ Time Frame: baseline, 1, 5 and 10 minutes during vibration, and 1 and 5 minutes after vibration ]
    maximal H-reflex amplitude (mV) recorded at mGCM
  • M amplitude [ Time Frame: 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 [ Time Frame: 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.
  • Resting motor threshold (RMT) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
Same as current
Not Provided
Not Provided
 
Developing Optimal Focal Muscle Vibration for Improving Spasticity
Optimization of Physical Focal Stimulation Parameters for Improving Spasticity and Identification of Neurophysiological Mechanism

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.

Not Provided
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
  • Vibration
  • Electrophysiology
  • Muscle Spasticity
Device: Focal muscular vibration
Experimental: Focal muscle 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

Intervention: Device: Focal muscular vibration
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
32
September 2014
March 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy volunteer

Exclusion Criteria:

  • Unstable medical conditions
  • History of epilepsy
  • History of drug abuse
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01915342
FMV07-2013-1010
Not Provided
Not Provided
Not Provided
Byung-Mo Oh, Seoul National University Hospital
Seoul National University Hospital
Korea Institute of Science and Technology
Not Provided
Seoul National University Hospital
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP