Developing Optimal Focal Muscle Vibration for Improving Spasticity

NCT01915342 | Completed

• 1 other identifier: FMV07-2013-1010
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vibration; Electrophysiology; Muscle Spasticity

Keywords

Monosynaptic reflex; H-reflex

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• H amplitude

  baseline, 1, 5 and 10 minutes during vibration, and 1 and 5 minutes after vibration

• M amplitude

  baseline, 1, 5 and 10 minutes during vibration, and 1 and 5 minutes after vibration

• motor evoked potential (MEP) amplitude

  baseline, 10 minutes during vibration, and 5 minutes after vibration

• Resting motor threshold (RMT)

  baseline, 10 minutes during vibration, and 5 minutes after vibration

• Short interval intracortical inhibition

  baseline, 10 minutes during vibration, and 5 minutes after vibration

Study Arms (1)

Focal muscle vibration

EXPERIMENTAL

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

Interventions

Focal muscular vibration DEVICE

Focal muscle vibration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteer

You may not qualify if:

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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Korea Institute of Science and Technology: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Muscle Spasticity

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Rehabilitation Medicine

Study Record Dates

• First Submitted: July 28, 2013
• First Posted: August 2, 2013
• Study Start: August 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: September 1, 2014
• Last Updated: October 10, 2014

Record last verified: 2014-10

Locations

KR (1)