Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00014976
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2001-04-17
Brief Title:
Physiologic Studies of Spasticity
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Spasticity Physiologic Studies
Status:
COMPLETED
Status Verified Date:
2010-11-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 01-N-0148 | None | None | None |