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Clinical Trials/NCT01915342
NCT01915342
Completed
Not Applicable

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

Seoul National University Hospital1 site in 1 country17 target enrollmentAugust 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Vibration
Sponsor
Seoul National University Hospital
Enrollment
17
Locations
1
Primary Endpoint
H/M ratio
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2013
End Date
September 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Byung-Mo Oh

Department of Rehabilitation Medicine

Seoul National University Hospital

Eligibility Criteria

Inclusion Criteria

  • Healthy volunteer

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

  • 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)
  • H amplitude(baseline, 1, 5 and 10 minutes during vibration, and 1 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)
  • Intracortical facilitation(baseline, 10 minutes during vibration, and 5 minutes after vibration)

Study Sites (1)

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