Developing Optimal Focal Muscle Vibration for Improving Spasticity

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Seoul National University Hospital
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: November 1, 2013
Last verified: November 2013
  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.


Estimated Enrollment: 32
Study Start Date: August 2013
Estimated Study Completion Date: August 2014
Estimated 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01915342

Contacts
Contact: Byung-Mo Oh, MD, PhD 82-2-2072-1358 keepwiz@gmail.com
Contact: Han Gil Seo, MD 82-2-2072-3401 acornjelly@gmail.com

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Byung-Mo Oh, MD, PhD    82-2-2072-1358    keepwiz@gmail.com   
Principal Investigator: Byung-Mo Oh, MD, PhD         
Sub-Investigator: Han Gil Seo, MD         
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: November 1, 2013
Health Authority: Korea: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on July 28, 2014