Demyelinating DiseaseNCT00001780
Magnetic Stimulation of the Human Nervous System
An observational study of Demyelinating Disease and Healthy, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
Transcranial Magnetic Stimulation (TMS) is a non-invasive technique to gather information about brain function. It is very useful when studying the areas of the brain related to motor activity (motor cortex, corticospinal tract, spinal cord and nerve roots). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Demyelinating Disease, Healthy, Lysosomal Storage Disease
- How many people
- 450 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 1998to Nov 2005
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Adult patients with weakness or motor dysfunction.
- Children and adolescents with corticospinal tract signs.
- Normal volunteers, adults.
- Normal volunteers, children aged 4-17.
Who cannot join
- Pregnant women.
- Subjects with implanted devices: pacemakers, medication pumps or defibrillators.
- Subjects with metal in the cranium except the mouth.
- Subjects with intracardiac lines.
- Normal subjects with history of seizures.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, 20892
About this study
Official title: Stimulation of the Human Central and Peripheral Nervous System With a Magnetic Stimulator
Transcranial Magnetic Stimulation (TMS) is a non-invasive technique to gather information about brain function. It is very useful when studying the areas of the brain related to motor activity (motor cortex, corticospinal tract, spinal cord and nerve roots). The procedure is conducted by transmitting a magnetic signal into the brain to stimulate an area of the body. Electrodes (small pieces of metal taped to areas of the body) are used in order to measure electrical activity. A magnetic signal is sent from a metal instrument held close to the patient's head, to an area of the brain responsible for motor activity of a certain area of the body. The electrodes pick up and record the electrical activity in the muscles.
This study will employ the use of TMS to diagnose neurological disorders that affect the motor cortex or the corticospinal tract. Normal subjects are sometimes studied to investigate normal activity of the nervous system and to train doctors in clinical neurophysiology and electrodiagnostic medicine at the National Institutes of Health (NIH).
Read the detailed description
This protocol outlines the use of magnetic stimulation as a diagnostic tool in patients with suspected dysfunction of central motor pathways or nerve roots and as a tool to localize and characterize suspected corticospinal abnormalities in neurologic disorders and systemic disorders with neurological manifestations. The protocol is intended for clinical use.
Transcranial magnetic stimulation has been used for diagnosis of neurologic disorders since 1987. The principles of magnetic stimulation and its use for diagnosis are described in current textbooks of clinical neurophysiology as a routine procedure and should be included in the training program for fellows in clinical neurophysiology and electrodiagnostic medicine at NIH.
The magnetic stimuli are to be given as single or paired pulses at repetition rates less than 1 per second.
- Conditions
- Demyelinating Disease, Healthy, Lysosomal Storage Disease, Motor Neuron Disease, Movement Disorder
- Keywords
- Myelopathy, Demyelination, Leukodystrophy, Motor Neuron Disease, Movement Disorders, Normal Volunteer
- Medical subject headings
- Demyelinating Diseases, Lysosomal Storage Diseases, Motor Neuron Disease, Movement Disorders, Spinal Cord Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study startFeb 1998
- Study completionNov 2005
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 Demyelinating DiseaseStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- 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
- 450 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001780
- Sponsor's protocol ID
- 980065
- Other IDs
- 98-N-0065
- Status last verified
- Nov 2005
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Eisen AA, Shtybel W. AAEM minimonograph #35: Clinical experience with transcranial magnetic stimulation. Muscle Nerve. 1990 Nov;13(11):995-1011. doi: 10.1002/mus.880131102.
PubMed 2233862Wassermann EM, Samii A, Mercuri B, Ikoma K, Oddo D, Grill SE, Hallett M. Responses to paired transcranial magnetic stimuli in resting, active, and recently activated muscles. Exp Brain Res. 1996 Apr;109(1):158-63. doi: 10.1007/BF00228638.
PubMed 8740220Muller K, Homberg V, Lenard HG. Magnetic stimulation of motor cortex and nerve roots in children. Maturation of cortico-motoneuronal projections. Electroencephalogr Clin Neurophysiol. 1991 Feb;81(1):63-70. doi: 10.1016/0168-5597(91)90105-7.
PubMed 1705221
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stimulation of the Human Central and Peripheral Nervous System With a Magnetic Stimulator
- ClinicalTrials.gov ID
- NCT00001780
- Acronym / sponsor ID
- 980065
- Conditions
- Demyelinating Disease, Healthy, Lysosomal Storage Disease, Motor Neuron Disease, Movement Disorder
- Keywords
- Myelopathy, Demyelination, Leukodystrophy, Motor Neuron Disease, Movement Disorders, Normal Volunteer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Feb 1998
- Study completion
- Nov 2005
- First posted
- 4 Nov 1999 (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.
Transcranial Magnetic Stimulation (TMS) is a non-invasive technique to gather information about brain function. It is very useful when studying the areas of the brain related to motor activity (motor cortex, corticospinal tract, spinal cord and nerve roots). The procedure is conducted by transmitting a magnetic signal into the brain to stimulate an area of the body. Electrodes (small pieces of metal taped to areas of the body) are used in order to measure electrical activity. A magnetic signal is sent from a metal instrument held close to the patient's head, to an area of the brain responsible for motor activity of a certain area of the body. The electrodes pick up and record the electrical activity in the muscles.
This study will employ the use of TMS to diagnose neurological disorders that affect the motor cortex or the corticospinal tract. Normal subjects are sometimes studied to investigate normal activity of the nervous system and to train doctors in clinical neurophysiology and electrodiagnostic medicine at the National Institutes of Health (NIH).
Detailed description
This protocol outlines the use of magnetic stimulation as a diagnostic tool in patients with suspected dysfunction of central motor pathways or nerve roots and as a tool to localize and characterize suspected corticospinal abnormalities in neurologic disorders and systemic disorders with neurological manifestations. The protocol is intended for clinical use.
Transcranial magnetic stimulation has been used for diagnosis of neurologic disorders since 1987. The principles of magnetic stimulation and its use for diagnosis are described in current textbooks of clinical neurophysiology as a routine procedure and should be included in the training program for fellows in clinical neurophysiology and electrodiagnostic medicine at NIH.
The magnetic stimuli are to be given as single or paired pulses at repetition rates less than 1 per second.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients with weakness or motor dysfunction.
- Children and adolescents with corticospinal tract signs.
- Normal volunteers, adults.
- Normal volunteers, children aged 4-17.
Key exclusion criteria (5 listed)
- Pregnant women.
- Subjects with implanted devices: pacemakers, medication pumps or defibrillators.
- Subjects with metal in the cranium except the mouth.
- Subjects with intracardiac lines.
- Normal subjects with 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 4 Mar 2008.
- Background: PubMed 2233862Eisen AA, Shtybel W. AAEM minimonograph #35: Clinical experience with transcranial magnetic stimulation. Muscle Nerve. 1990 Nov;13(11):995-1011. doi: 10.1002/mus.880131102.
- Background: PubMed 8740220Wassermann EM, Samii A, Mercuri B, Ikoma K, Oddo D, Grill SE, Hallett M. Responses to paired transcranial magnetic stimuli in resting, active, and recently activated muscles. Exp Brain Res. 1996 Apr;109(1):158-63. doi: 10.1007/BF00228638.
- Background: PubMed 1705221Muller K, Homberg V, Lenard HG. Magnetic stimulation of motor cortex and nerve roots in children. Maturation of cortico-motoneuronal projections. Electroencephalogr Clin Neurophysiol. 1991 Feb;81(1):63-70. doi: 10.1016/0168-5597(91)90105-7.
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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 Demyelinating Disease 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 5 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 4 Mar 2008. 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 NCT00001780, 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 4 Mar 2008.