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Completed

NCT Number: NCT01915342

Developing Optimal Focal Muscle Vibration for Improving Spasticity

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.

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Key information

Conditions

Vibration Electrophysiology Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy volunteer

Exclusion criteria

  • Unstable medical conditions
  • History of epilepsy
  • History of drug abuse

Treatment and study plan

Focal muscular vibration

Device

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Korea Institute of Science and Technology

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Aug 2, 2013
Registry last updated
Oct 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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