Movement DisorderNCT00017966
Brain Excitability During Self-Paced Voluntary Movements
An observational study of Movement Disorder and Healthy, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study will use transcranial magnetic stimulation to examine how the brain controls movement by sending messages to the spinal cord and muscles and what goes wrong with this process in disease. Normal healthy volunteers 18 years of age and older may be eligible to participate. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Movement Disorder, Healthy
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2001to Jun 2002
- 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
Normal adult volunteers 18 or more years old.
Subjects must not have medico-surgical illness.
Subjects must not have neurological illness.
Subjects must not have psychiatric illness.
Subjects must not be taking any medication with potential influence on nervous system function.
Subjects must not have a pacemaker.
Subject must not have an implanted medical pump.
Subjects must not have a metal plate or a metal object in the skull or eye.
Subjects must not have a history of seizure disorder.
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: Cortical Excitability During Self-Paced Voluntary Movements
This study will use transcranial magnetic stimulation to examine how the brain controls movement by sending messages to the spinal cord and muscles and what goes wrong with this process in disease. Normal healthy volunteers 18 years of age and older may be eligible to participate.
In transcranial magnetic stimulation, an insulated wire coil is placed on the subject's scalp or skin. Brief electrical currents are passed through the coil, creating magnetic pulses that stimulate the brain. During the stimulation, participants will be asked to tense certain muscles slightly or perform other simple actions. The electrical activity of the muscle will be recorded on a computer through electrodes applied to the skin over the muscle. In most cases, the study will last less than 3 hours.
Read the detailed description
The purpose of this study is to investigate the influence of volitional movement on excitability of ipsilateral as well as contralateral motor cortical neurons controlling homologous and surrounding muscles. Transcallosal and surrounding inhibitions are well known phenomenon to suppress unwanted movements during voluntary action, which is often disturbed in various movement disorders. Transcranial magnetic stimulation (TMS) has been used to investigate these inhibitory mechanisms, but the inhibitory influence during and after voluntary movement has not been well elucidated yet. In normal volunteers, we plan to determine if voluntary movements of one finger influence the cortical excitability responsible for surrounding as well as contralateral homologous muscles, using voluntary movement-triggered TMS. The primary outcome measures would be any changes in motor evoked potential (MEP) size and intracortical inhibition (ICI) parameters.
- Conditions
- Movement Disorder, Healthy
- Keywords
- Transcranial Magnetic Stimulation, Motor Cortex, Cerebral Inhibition, Corpus Callosum, Evoked Potential, Healthy Volunteer, Normal Control
- Medical subject headings
- Movement Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2001 (estimated)
- Study startJun 2001
- Study completionJun 2002
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 Movement DisorderStudies 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
- 30 participants
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
- NCT00017966
- Sponsor's protocol ID
- 010199
- Other IDs
- 01-N-0199
- Status last verified
- Jun 2002
- First submitted
- 23 Jun 2001
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Blakemore C, Carpenter RH, Georgeson MA. Lateral inhibition between orientation detectors in the human visual system. Nature. 1970 Oct 3;228(5266):37-9. doi: 10.1038/228037a0. No abstract available.
PubMed 5456209Prince DA, Wilder BJ. Control mechanisms in cortical epileptogenic foci. "Surround" inhibition. Arch Neurol. 1967 Feb;16(2):194-202. doi: 10.1001/archneur.1967.00470200082007. No abstract available.
PubMed 6018049Krnjevic K. Role of GABA in cerebral cortex. Can J Physiol Pharmacol. 1997 May;75(5):439-51. No abstract available.
PubMed 9250378
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
- Cortical Excitability During Self-Paced Voluntary Movements
- ClinicalTrials.gov ID
- NCT00017966
- Acronym / sponsor ID
- 010199
- Conditions
- Movement Disorder, Healthy
- Keywords
- Transcranial Magnetic Stimulation, Motor Cortex, Cerebral Inhibition, Corpus Callosum, Evoked Potential, Healthy Volunteer, Normal Control
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Jun 2001
- Study completion
- Jun 2002
- First posted
- 25 Jun 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 use transcranial magnetic stimulation to examine how the brain controls movement by sending messages to the spinal cord and muscles and what goes wrong with this process in disease. Normal healthy volunteers 18 years of age and older may be eligible to participate.
In transcranial magnetic stimulation, an insulated wire coil is placed on the subject's scalp or skin. Brief electrical currents are passed through the coil, creating magnetic pulses that stimulate the brain. During the stimulation, participants will be asked to tense certain muscles slightly or perform other simple actions. The electrical activity of the muscle will be recorded on a computer through electrodes applied to the skin over the muscle. In most cases, the study will last less than 3 hours.
Detailed description
The purpose of this study is to investigate the influence of volitional movement on excitability of ipsilateral as well as contralateral motor cortical neurons controlling homologous and surrounding muscles. Transcallosal and surrounding inhibitions are well known phenomenon to suppress unwanted movements during voluntary action, which is often disturbed in various movement disorders. Transcranial magnetic stimulation (TMS) has been used to investigate these inhibitory mechanisms, but the inhibitory influence during and after voluntary movement has not been well elucidated yet. In normal volunteers, we plan to determine if voluntary movements of one finger influence the cortical excitability responsible for surrounding as well as contralateral homologous muscles, using voluntary movement-triggered TMS. The primary outcome measures would be any changes in motor evoked potential (MEP) size and intracortical inhibition (ICI) parameters.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
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 5456209Blakemore C, Carpenter RH, Georgeson MA. Lateral inhibition between orientation detectors in the human visual system. Nature. 1970 Oct 3;228(5266):37-9. doi: 10.1038/228037a0. No abstract available.
- Background: PubMed 6018049Prince DA, Wilder BJ. Control mechanisms in cortical epileptogenic foci. "Surround" inhibition. Arch Neurol. 1967 Feb;16(2):194-202. doi: 10.1001/archneur.1967.00470200082007. No abstract available.
- Background: PubMed 9250378Krnjevic K. Role of GABA in cerebral cortex. Can J Physiol Pharmacol. 1997 May;75(5):439-51. No abstract available.
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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 Movement Disorder 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.
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 NCT00017966, 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.