Physiologic Studies of Spasticity

Healthy Clinical Trial

Official title:

Spasticity: Physiologic Studies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00014976
• Other study ID #: 010148
• Secondary ID: 01-N-0148
• Status: Completed
• Phase: N/A
• First received: April 17, 2001
• Last updated: June 30, 2017
• Start date: April 13, 2001
• Est. completion date: November 1, 2010

Study information

• Verified date: November 1, 2010
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: November 1, 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

• 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

Related Conditions & MeSH terms

• Healthy
• Muscle Spasticity

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center, 9000 Rockville Pike	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation