Physiologic Studies of Spasticity
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|ClinicalTrials.gov Identifier: NCT00014976|
Recruitment Status : Completed
First Posted : April 18, 2001
Last Update Posted : July 2, 2017
|First Submitted Date||April 17, 2001|
|First Posted Date||April 18, 2001|
|Last Update Posted Date||July 2, 2017|
|Study Start Date||April 13, 2001|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures||Not Provided|
|Original Primary Outcome Measures||Not Provided|
|Change History||Complete list of historical versions of study NCT00014976 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures||Not Provided|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title||Physiologic Studies of Spasticity|
|Official Title||Spasticity: Physiologic Studies|
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.
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 Design||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Study Completion Date||November 1, 2010|
|Primary Completion Date||Not Provided|
Adult patients with selective corticospinal tract dysfunction
Minimum age 21 years; maximum age 80 years
Moderate severity of weakness (greater than or equal to MRC Grade 4)
Adult normal volunteers
Severe weakness with inability to maintain voluntary contractions
Significant sensory impairment
For TMS studies only: pregnancy, implanted devices such as pacemakers, medication pumps or defibrillators, metal in the cranium except the mouth, intracardiac lines, history of seizures
|Ages||21 Years to 80 Years (Adult, Older Adult)|
|Accepts Healthy Volunteers||Yes|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||United States|
|Removed Location Countries|
|Other Study ID Numbers||010148
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor||National Institute of Neurological Disorders and Stroke (NINDS)|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||November 1, 2010|