Muscle Spasticity Clinical Trial
Official title:
Optimization of Physical Focal Stimulation Parameters for Improving Spasticity and Identification of Neurophysiological Mechanism
Verified date | October 2014 |
Source | Seoul National University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 17 |
Est. completion date | September 2014 |
Est. primary completion date | March 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Healthy volunteer Exclusion Criteria: - Unstable medical conditions - History of epilepsy - History of drug abuse |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital | Korea Institute of Science and Technology |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | H amplitude | maximal H-reflex amplitude (mV) recorded at mGCM | baseline, 1, 5 and 10 minutes during vibration, and 1 and 5 minutes after vibration | No |
Secondary | M amplitude | CMAP amplitude (mV) recorded at mGCM | baseline, 1, 5 and 10 minutes during vibration, and 1 and 5 minutes after vibration | No |
Secondary | motor evoked potential (MEP) amplitude | Transcranial magnetic stimulation on the contralateral leg motor cortex is used to measure MEP at mGCM. | baseline, 10 minutes during vibration, and 5 minutes after vibration | No |
Secondary | Resting motor threshold (RMT) | 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. | baseline, 10 minutes during vibration, and 5 minutes after vibration | No |
Secondary | Short interval intracortical inhibition | Short interval intracortical inhibition is recorded by using conditioning stimulus of 90% RMT and test stimulus of 120% RMT with 1ms interval. | baseline, 10 minutes during vibration, and 5 minutes after vibration | No |
Secondary | Intracortical facilitation | Intracortical facilitation is recorded by using conditioning stimulus of 90% RMT and test stimulus of 120% RMT with 10ms interval. | baseline, 10 minutes during vibration, and 5 minutes after vibration | No |
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