Physiologic Studies of Spasticity
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00014976|
Recruitment Status : Completed
First Posted : April 18, 2001
Last Update Posted : July 2, 2017
This study will provide information about changes that occur in the motor neurons of the spinal cord (the nerve cells that control the muscles) when the motor cortex (the region of the brain that controls movement) is unable to send messages to the spinal cord and muscles in the normal way. This information will help elucidate how the nervous system adapts after injury or disease of the motor cortex.
Healthy adult volunteers and adults with a spasticity disorder and moderate weakness may be eligible for this study. Patients will be screened with a medical history, physical examination and diagnostic studies as needed. Healthy volunteers will have a neurological examination. Muscle weakness and spasticity will be evaluated in both groups of subjects.
All participants will have electromyography (measurement of electrical activity in muscles) during nerve stimulation and transcranial magnetic stimulation, described below. (Some patients, such as those with a pacemaker or implanted medication pumps, metal objects in the eye, history of epilepsy and others, will not have magnetic stimulation.)
Electromyography - The electrical activity of muscles will be measured either by 1) using metal electrodes taped to the skin overlying a muscle, or 2) using thin wires inserted into the muscle through a needle.
Nerve stimulation - The nerves will be stimulated by applying a small electrical pulse through metal disks on the skin of the arm or leg.
Transcranial magnetic stimulation - A brief electrical current is passed through a wire coil placed on the scalp. This creates a magnetic pulse, which stimulates the brain. During the test, the participant may be asked to tense certain muscles slightly or perform other simple actions.
Nerve block - Some patients will have a nerve block of one of the nerves in the arm. For this procedure, a local anesthetic is injected under the skin to produce numbness and weakness in some arm muscles.
|Condition or disease|
|Muscle Spasticity Healthy|
Objective: The purpose of this protocol is to characterize abnormalities in motoneuron recruitment in adult patients with corticospinal tract dysfunction using electrophysiologic measures. We wish to determine whether the intrinsic spinal mechanisms for recruitment are abnormal or whether only inputs to motoneurons are changed. This information is pertinent for assessing ways that can ultimately be used to enhance strength in patients with corticospinal tract dysfunction using the existing spinal circuitry.
Study Design: Comparison of physiological observations in patients and age - matched control subjects.
Study Population: Adults with spastic paresis aged 21-80 and healthy volunteers.
Outcome Parameters: Measures of motor unit firing in response to peripheral nerve stimulation and transcranial magnetic stimulation.
|Study Type :||Observational|
|Actual Enrollment :||48 participants|
|Official Title:||Spasticity: Physiologic Studies|
|Study Start Date :||April 13, 2001|
|Study Completion Date :||November 1, 2010|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00014976
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|