Muscle SpasticityNCT00014976
Physiologic Studies of Spasticity
An observational study of Muscle Spasticity and Healthy, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Spasticity, Healthy
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2001to 1 Nov 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Muscle Spasticity, Healthy
- Keywords
- Pyramidal Tract, Primary Lateral Sclerosis, Spastic Paraparesis, EMG, Magnetic Stimulation, Muscle Spasticity, Healthy Volunteer
- Medical subject headings
- Muscle Spasticity, Motor Neuron Disease, Paraparesis, Spastic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2001 (estimated)
- Study start13 Apr 2001
- Study completion1 Nov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Muscle SpasticityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00014976
- Sponsor's protocol ID
- 010148
- Other IDs
- 01-N-0148
- Status last verified
- 1 Nov 2010
- First submitted
- 17 Apr 2001
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
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.
PubMed 7659104Rosenfalck 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.
PubMed 7441270Frascarelli M, Mastrogregori L, Conforti L. Initial motor unit recruitment in patients with spastic hemiplegia. Electromyogr Clin Neurophysiol. 1998 Jul-Aug;38(5):267-71.
PubMed 9741003
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spasticity: Physiologic Studies
- ClinicalTrials.gov ID
- NCT00014976
- Acronym / sponsor ID
- 010148
- Conditions
- Muscle Spasticity, Healthy
- Keywords
- Pyramidal Tract, Primary Lateral Sclerosis, Spastic Paraparesis, EMG, Magnetic Stimulation, Muscle Spasticity, Healthy Volunteer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 13 Apr 2001
- Study completion
- 1 Nov 2010
- First posted
- 18 Apr 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 7659104Gemperline 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.
- Background: PubMed 7441270Rosenfalck 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.
- Background: PubMed 9741003Frascarelli M, Mastrogregori L, Conforti L. Initial motor unit recruitment in patients with spastic hemiplegia. Electromyogr Clin Neurophysiol. 1998 Jul-Aug;38(5):267-71.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Muscle Spasticity and Healthy, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00014976, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017; AzTrials last refreshed its copy on 27 Oct 2026.