Developing Optimal Focal Muscle Vibration for Improving Spasticity

This study has been completed.
Sponsor:
Collaborator:
Korea Institute of Science and Technology
Information provided by (Responsible Party):
Byung-Mo Oh, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01915342
First received: July 28, 2013
Last updated: October 8, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention
Vibration
Electrophysiology
Muscle Spasticity
Device: Focal muscular vibration

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Optimization of Physical Focal Stimulation Parameters for Improving Spasticity and Identification of Neurophysiological Mechanism

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • H/M ratio [ Time Frame: baseline, 1, 5 and 10 minutes during vibration, and 1 and 5 minutes after vibration ] [ Designated as safety issue: No ]
    The ratio of maximal H-reflex amplitude (mV) to CMAP amplitude (mV) recorded at mGCM


Secondary Outcome Measures:
  • H amplitude [ Time Frame: baseline, 1, 5 and 10 minutes during vibration, and 1 and 5 minutes after vibration ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    CMAP amplitude (mV) recorded at mGCM

  • motor evoked potential (MEP) amplitude [ Time Frame: baseline, 10 minutes during vibration, and 5 minutes after vibration ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Intracortical facilitation is recorded by using conditioning stimulus of 90% RMT and test stimulus of 120% RMT with 10ms interval.


Enrollment: 17
Study Start Date: August 2013
Study Completion Date: September 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Device: Focal muscular vibration

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteer

Exclusion Criteria:

  • Unstable medical conditions
  • History of epilepsy
  • History of drug abuse
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01915342

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Korea Institute of Science and Technology
  More Information

No publications provided

Responsible Party: Byung-Mo Oh, Department of Rehabilitation Medicine, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01915342     History of Changes
Other Study ID Numbers: FMV07-2013-1010
Study First Received: July 28, 2013
Last Updated: October 8, 2014
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
Monosynaptic reflex
H-reflex

Additional relevant MeSH terms:
Muscle Spasticity
Muscle Hypertonia
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on October 21, 2014