HealthyNCT00030199
Brain Control of Blinking
An observational study of 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 (TMS) to study how the brain controls movement of muscles in the face-in particular, those involved in eye blinking. TMS is a procedure that activates areas of the brain with magnetic pulses that travel through the scalp and the skull. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2002to Feb 2004
- 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
- Inclusion criteria of this study are normal adult volunteers who are greater than or equal to 21 years old.
Who cannot join
- Exclusion criteria are those who have either any medico-surgical, neurological and psychiatric illness, who have been taking any medication with potential influence on nervous system function;
- who have a pacemaker;
- an implanted medical pump;
- a metal plate or a metal object in the skull or eye (for example, after brain surgery); or
- who 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 Control of Voluntary Blinking
This study will use transcranial magnetic stimulation (TMS) to study how the brain controls movement of muscles in the face-in particular, those involved in eye blinking. TMS is a procedure that activates areas of the brain with magnetic pulses that travel through the scalp and the skull.
Healthy normal volunteers 21 years of age and older may be eligible for this study. They must be free of any serious medical illness, have no neurological or psychiatric disorders or history of seizures, and must not be taking any medications that can affect nervous system function.
Read more
Participants will undergo TMS and the electrical activity in muscles activated by the stimulation will be recorded. For TMS, an insulated wire coil is placed on the patient's scalp, and a brief electrical current is passed through the coil. This creates a magnetic pulse that travels through the scalp and skull and causes small electrical currents in the outer part of the brain. If the coil is placed over a nerve that controls muscles, there may be a twitch in the muscles, sometimes large enough to move the face. In other cases, there may be a feeling of movement or tingling sensation in the face. Stimulation over the muscles on the side of the head may cause some discomfort there or twitching of the jaw. During the stimulation, subjects may be asked to tense certain muscles slightly or perform other simple actions.
Electrical activity of the muscles activated by the stimulation is recorded. This is done with both metal electrodes taped to the skin over the muscle and with fine needle electrodes inserted into the muscles around the eyes.
The study usually takes less than 3 hours, with frequent breaks. If more time is required, the study will be broken into more than one session.
Read the detailed description
The purpose of this study is to investigate the cortical center for voluntary control of eyelid closure using transcranial magnetic stimulation (TMS). Conventionally the primary motor cortex (M1) has been thought to control upper facial movement . However, recent neuroanatomical and neuroimaging studies suggest that the upper facial muscles are mainly controlled by the mesial frontal region, not M1 . Recently, we performed a transcranial magnetic stimulation (TMS) study to investigate the cortical center for the upper facial muscles, especially those related to blinking, and observed possible cortical responses from the surface electrodes attached to the orbicularis oculi (OOC) muscles with the stimulation applied to the mesial frontal region. In this study, we are planning to use monopolar needle electrodes to confirm that these responses originate from the cortical stimulation.
- Conditions
- Healthy
- Keywords
- Transcranial Magnetic Stimuli, Eletromyography, Needle Electrode, Facial Muscles, Blink Reflex, Motor Cortex, Transcranial Magnetic Stimulation, Healthy Volunteer, HV, Normal Control
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2002 (estimated)
- Study startFeb 2002
- Study completionFeb 2004
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 HealthyStudies 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
- 10 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
- NCT00030199
- Sponsor's protocol ID
- 020119
- Other IDs
- 02-N-0119
- Status last verified
- Feb 2004
- First submitted
- 7 Feb 2002
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Jenny AB, Saper CB. Organization of the facial nucleus and corticofacial projection in the monkey: a reconsideration of the upper motor neuron facial palsy. Neurology. 1987 Jun;37(6):930-9. doi: 10.1212/wnl.37.6.930.
PubMed 3587643Tsubota K, Kwong KK, Lee TY, Nakamura J, Cheng HM. Functional MRI of brain activation by eye blinking. Exp Eye Res. 1999 Jul;69(1):1-7. doi: 10.1006/exer.1999.0660.
PubMed 10375444Morecraft RJ, Louie JL, Herrick JL, Stilwell-Morecraft KS. Cortical innervation of the facial nucleus in the non-human primate: a new interpretation of the effects of stroke and related subtotal brain trauma on the muscles of facial expression. Brain. 2001 Jan;124(Pt 1):176-208. doi: 10.1093/brain/124.1.176.
PubMed 11133797
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 Control of Voluntary Blinking
- ClinicalTrials.gov ID
- NCT00030199
- Acronym / sponsor ID
- 020119
- Conditions
- Healthy
- Keywords
- Transcranial Magnetic Stimuli, Eletromyography, Needle Electrode, Facial Muscles, Blink Reflex, Motor Cortex, Transcranial Magnetic Stimulation, Healthy Volunteer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Feb 2002
- Study completion
- Feb 2004
- First posted
- 8 Feb 2002 (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 (TMS) to study how the brain controls movement of muscles in the face-in particular, those involved in eye blinking. TMS is a procedure that activates areas of the brain with magnetic pulses that travel through the scalp and the skull.
Healthy normal volunteers 21 years of age and older may be eligible for this study. They must be free of any serious medical illness, have no neurological or psychiatric disorders or history of seizures, and must not be taking any medications that can affect nervous system function.
Participants will undergo TMS and the electrical activity in muscles activated by the stimulation will be recorded. For TMS, an insulated wire coil is placed on the patient's scalp, and a brief electrical current is passed through the coil. This creates a magnetic pulse that travels through the scalp and skull and causes small electrical currents in the outer part of the brain. If the coil is placed over a nerve that controls muscles, there may be a twitch in the muscles, sometimes large enough to move the face. In other cases, there may be a feeling of movement or tingling sensation in the face. Stimulation over the muscles on the side of the head may cause some discomfort there or twitching of the jaw. During the stimulation, subjects may be asked to tense certain muscles slightly or perform other simple actions.
Electrical activity of the muscles activated by the stimulation is recorded. This is done with both metal electrodes taped to the skin over the muscle and with fine needle electrodes inserted into the muscles around the eyes.
The study usually takes less than 3 hours, with frequent breaks. If more time is required, the study will be broken into more than one session.
Detailed description
The purpose of this study is to investigate the cortical center for voluntary control of eyelid closure using transcranial magnetic stimulation (TMS). Conventionally the primary motor cortex (M1) has been thought to control upper facial movement . However, recent neuroanatomical and neuroimaging studies suggest that the upper facial muscles are mainly controlled by the mesial frontal region, not M1 . Recently, we performed a transcranial magnetic stimulation (TMS) study to investigate the cortical center for the upper facial muscles, especially those related to blinking, and observed possible cortical responses from the surface electrodes attached to the orbicularis oculi (OOC) muscles with the stimulation applied to the mesial frontal region. In this study, we are planning to use monopolar needle electrodes to confirm that these responses originate from the cortical stimulation.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Inclusion criteria of this study are normal adult volunteers who are greater than or equal to 21 years old.
Key exclusion criteria (5 listed)
- Exclusion criteria are those who have either any medico-surgical, neurological and psychiatric illness, who have been taking any medication with potential influence on nervous system function;
- who have a pacemaker;
- an implanted medical pump;
- a metal plate or a metal object in the skull or eye (for example, after brain surgery); or
- who have a history of seizure disorder.
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 3587643Jenny AB, Saper CB. Organization of the facial nucleus and corticofacial projection in the monkey: a reconsideration of the upper motor neuron facial palsy. Neurology. 1987 Jun;37(6):930-9. doi: 10.1212/wnl.37.6.930.
- Background: PubMed 10375444Tsubota K, Kwong KK, Lee TY, Nakamura J, Cheng HM. Functional MRI of brain activation by eye blinking. Exp Eye Res. 1999 Jul;69(1):1-7. doi: 10.1006/exer.1999.0660.
- Background: PubMed 11133797Morecraft RJ, Louie JL, Herrick JL, Stilwell-Morecraft KS. Cortical innervation of the facial nucleus in the non-human primate: a new interpretation of the effects of stroke and related subtotal brain trauma on the muscles of facial expression. Brain. 2001 Jan;124(Pt 1):176-208. doi: 10.1093/brain/124.1.176.
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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 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 1 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 NCT00030199, 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.