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Physiologic Studies of Spasticity

Primary Purpose

Muscle Spasticity, Healthy

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Institute of Neurological Disorders and Stroke (NINDS)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Muscle Spasticity focused on measuring Pyramidal Tract, Primary Lateral Sclerosis, Spastic Paraparesis, EMG, Magnetic Stimulation, Muscle Spasticity, Healthy Volunteer

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

INCLUSION CRITERIA: 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 EXCLUSION CRITERIA: 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

Sites / Locations

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 17, 2001
Last Updated
June 30, 2017
Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT00014976
Brief Title
Physiologic Studies of Spasticity
Official Title
Spasticity: Physiologic Studies
Study Type
Observational

2. Study Status

Record Verification Date
November 1, 2010
Overall Recruitment Status
Completed
Study Start Date
April 13, 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 1, 2010 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Spasticity, Healthy
Keywords
Pyramidal Tract, Primary Lateral Sclerosis, Spastic Paraparesis, EMG, Magnetic Stimulation, Muscle Spasticity, Healthy Volunteer

7. Study Design

Enrollment
48 (Actual)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
INCLUSION CRITERIA: 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 EXCLUSION CRITERIA: 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
Facility Information:
Facility Name
National Institutes of Health Clinical Center, 9000 Rockville Pike
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
7659104
Citation
Gemperline JJ, Allen S, Walk D, Rymer WZ. Characteristics of motor unit discharge in subjects with hemiparesis. Muscle Nerve. 1995 Oct;18(10):1101-14. doi: 10.1002/mus.880181006.
Results Reference
background
PubMed Identifier
7441270
Citation
Rosenfalck A, Andreassen S. Impaired regulation of force and firing pattern of single motor units in patients with spasticity. J Neurol Neurosurg Psychiatry. 1980 Oct;43(10):907-16. doi: 10.1136/jnnp.43.10.907.
Results Reference
background
PubMed Identifier
9741003
Citation
Frascarelli M, Mastrogregori L, Conforti L. Initial motor unit recruitment in patients with spastic hemiplegia. Electromyogr Clin Neurophysiol. 1998 Jul-Aug;38(5):267-71.
Results Reference
background

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Physiologic Studies of Spasticity

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