HealthyNCT00096564
Brain Activities Associated With Different Facial Expressions Using Blood Oxygenation Level Dependent Functional MRI
An observational study of Healthy, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
Objectives: The purpose of this study is to identify areas of brain activation during the urge to yawn. Little is known about how yawning is suppressed, or why yawning often occurs in response to seeing another person yawn (contagious yawning). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2004to 20 Aug 2008
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects age 18 and older.
- Subjects willing to abstain from caffeine or alcohol for 48 hours prior to the fMRI scanning.
Who cannot join
- Subjects with any abnormal findings on neurological exam.
- Subjects with a positive urine pregnancy test.
- Subjects who are pregnant.
- Subjects with any finding on the MRI safety questionnaire which prevents them from safely undergoing an MRI scan.
- Subjects with any history of brain tumor, stroke, head trauma or a vascular malformation as obtained by history or from imaging studies.
- Subjects with any history of a severe medical condition, such as cardiovascular disease, which would prevent them from lying flat for up to 60 minutes.
- Subjects without the capacity to give informed consent.
- Subjects with claustrophobia or other restrictions which prevent them from undergoing a scan in a confined space for up to 60 minutes.
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: Functional MRI Study of Brain Activation With Observation of Facial Expressions
Objectives: The purpose of this study is to identify areas of brain activation during the urge to yawn. Little is known about how yawning is suppressed, or why yawning often occurs in response to seeing another person yawn (contagious yawning). Contagious yawning is similar to other contagious motor programs, such as the greater urge Tourette subjects feel to tic when seeing repetitive movements or other subjects' tics, the urge to scratch when discussing itching and scratching, or the urge to urinate when hearing running water. Hypothetically, the urge or the suppression of this urge is modulated by a common cortical circuit implicated in Tourette syndrome. We plan to use functional magnetic resonance imaging (fMRI) to identify the pattern of blood oxygenation level-dependent (BOLD) activation in the brain when normal volunteers feel the urge to yawn.
Study Population: We intend to study 25 normal, right-handed, healthy volunteers.
Read more
Study Design: Using an event-related design, we will scan subjects, using the same 3T fMRI scanner, while showing a video of a person yawning, gaping, coughing, or doing nothing. Each of these four action stimuli will last for four seconds, with varying interstimulus intervals. Each video set will contain all actions displayed ten times pseudorandomly. Two data sets will be collected from each subject and will be separated by a brief rest period. Subjects will be instructed before the scan to watch a videotaped person perform various behaviors, without detailing the specific actions. So as not to influence their natural response to the yawning stimulus, we will instruct them only to keep their head still. The variable of interest will be the activation during urge-generation, contrasted with other control stimuli. A survey will be administered for informational purposes following the scan to assess the subjects' general impression of their susceptibility to yawning, whether they yawned in the scanner, whether they suppressed the urge to yawn, and if the urge to yawn increased or decreased with the repetition of the yawning segment.
Outcome Measures: The primary outcome of this study is the activation of brain structures in response to viewing another person yawning. In particular, we are interested in the activation of the anterior cingulate cortex, parietal operculum, insula, supplementary motor area, and dorsolateral prefrontal cortex as these are areas implicated in the urge to move in response to either internal (as in Tourette syndrome) or external (as in itching from histamine injection) states. Since the urge to yawn is the process of interest, suppression of yawning is not relevant to the fMRI analysis.
Read the detailed description
Purpose of this study
This study will look at how perception and observation of various facial expressions may affect the way different areas of the brain function. We hope to gain a greater understanding of abnormal movements, such as tics, by investigating how facial expressions affect the brain.
Background Information
This study is based on prior research that focuses on the activity and changes in different areas of the brain depending on what people see others around them doing. An example is the feeling of empathy one might have when looking at a sad face, or anxiety and fear when looking at an angry face.
Who is the Study Population?
20 healthy, right-handed men and women
- Conditions
- Healthy
- Keywords
- Mirror Neuron, Urge, Statistical Parametric Mapping, Healthy Volunteer, HV
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2004 (estimated)
- Study start9 Nov 2004
- Study completion20 Aug 2008
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.
- 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
- 25 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00096564
- Sponsor's protocol ID
- 050032
- Other IDs
- 05-N-0032
- Status last verified
- 20 Aug 2008
- First submitted
- 10 Nov 2004
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Argiolas A, Melis MR. The neuropharmacology of yawning. Eur J Pharmacol. 1998 Feb 5;343(1):1-16. doi: 10.1016/s0014-2999(97)01538-0.
PubMed 9551709Askenasy JJ. Is yawning an arousal defense reflex? J Psychol. 1989 Nov;123(6):609-21. doi: 10.1080/00223980.1989.10543014.
PubMed 2558182Athwal BS, Berkley KJ, Hussain I, Brennan A, Craggs M, Sakakibara R, Frackowiak RS, Fowler CJ. Brain responses to changes in bladder volume and urge to void in healthy men. Brain. 2001 Feb;124(Pt 2):369-77. doi: 10.1093/brain/124.2.369.
PubMed 11157564
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
- Functional MRI Study of Brain Activation With Observation of Facial Expressions
- ClinicalTrials.gov ID
- NCT00096564
- Acronym / sponsor ID
- 050032
- Conditions
- Healthy
- Keywords
- Mirror Neuron, Urge, Statistical Parametric Mapping, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 9 Nov 2004
- Study completion
- 20 Aug 2008
- First posted
- 11 Nov 2004 (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.
Objectives: The purpose of this study is to identify areas of brain activation during the urge to yawn. Little is known about how yawning is suppressed, or why yawning often occurs in response to seeing another person yawn (contagious yawning). Contagious yawning is similar to other contagious motor programs, such as the greater urge Tourette subjects feel to tic when seeing repetitive movements or other subjects' tics, the urge to scratch when discussing itching and scratching, or the urge to urinate when hearing running water. Hypothetically, the urge or the suppression of this urge is modulated by a common cortical circuit implicated in Tourette syndrome. We plan to use functional magnetic resonance imaging (fMRI) to identify the pattern of blood oxygenation level-dependent (BOLD) activation in the brain when normal volunteers feel the urge to yawn.
Study Population: We intend to study 25 normal, right-handed, healthy volunteers.
Study Design: Using an event-related design, we will scan subjects, using the same 3T fMRI scanner, while showing a video of a person yawning, gaping, coughing, or doing nothing. Each of these four action stimuli will last for four seconds, with varying interstimulus intervals. Each video set will contain all actions displayed ten times pseudorandomly. Two data sets will be collected from each subject and will be separated by a brief rest period. Subjects will be instructed before the scan to watch a videotaped person perform various behaviors, without detailing the specific actions. So as not to influence their natural response to the yawning stimulus, we will instruct them only to keep their head still. The variable of interest will be the activation during urge-generation, contrasted with other control stimuli. A survey will be administered for informational purposes following the scan to assess the subjects' general impression of their susceptibility to yawning, whether they yawned in the scanner, whether they suppressed the urge to yawn, and if the urge to yawn increased or decreased with the repetition of the yawning segment.
Outcome Measures: The primary outcome of this study is the activation of brain structures in response to viewing another person yawning. In particular, we are interested in the activation of the anterior cingulate cortex, parietal operculum, insula, supplementary motor area, and dorsolateral prefrontal cortex as these are areas implicated in the urge to move in response to either internal (as in Tourette syndrome) or external (as in itching from histamine injection) states. Since the urge to yawn is the process of interest, suppression of yawning is not relevant to the fMRI analysis.
Detailed description
Purpose of this study
This study will look at how perception and observation of various facial expressions may affect the way different areas of the brain function. We hope to gain a greater understanding of abnormal movements, such as tics, by investigating how facial expressions affect the brain.
Background Information
This study is based on prior research that focuses on the activity and changes in different areas of the brain depending on what people see others around them doing. An example is the feeling of empathy one might have when looking at a sad face, or anxiety and fear when looking at an angry face.
Who is the Study Population?
20 healthy, right-handed men and women
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects age 18 and older.
- Subjects willing to abstain from caffeine or alcohol for 48 hours prior to the fMRI scanning.
Key exclusion criteria (8 listed)
- Subjects with any abnormal findings on neurological exam.
- Subjects with a positive urine pregnancy test.
- Subjects who are pregnant.
- Subjects with any finding on the MRI safety questionnaire which prevents them from safely undergoing an MRI scan.
- Subjects with any history of brain tumor, stroke, head trauma or a vascular malformation as obtained by history or from imaging studies.
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 9551709Argiolas A, Melis MR. The neuropharmacology of yawning. Eur J Pharmacol. 1998 Feb 5;343(1):1-16. doi: 10.1016/s0014-2999(97)01538-0.
- Background: PubMed 2558182Askenasy JJ. Is yawning an arousal defense reflex? J Psychol. 1989 Nov;123(6):609-21. doi: 10.1080/00223980.1989.10543014.
- Background: PubMed 11157564Athwal BS, Berkley KJ, Hussain I, Brennan A, Craggs M, Sakakibara R, Frackowiak RS, Fowler CJ. Brain responses to changes in bladder volume and urge to void in healthy men. Brain. 2001 Feb;124(Pt 2):369-77. doi: 10.1093/brain/124.2.369.
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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 2 inclusion and 8 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 NCT00096564, 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.