HealthyNCT00088712
Event Related Potentials in Infants and Adults
An observational study of Healthy and Child Development, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial summary
This study will explore the development of visual perception and the brain activity that underlies it. It will examine electrical activity in the brain while people are processing characteristics of the visual environment, and how that processing might change with development. Read more about this study
- Who is it for?
- Ages 3 months to 45 years
- Conditions the study is for
- Healthy, Child Development
- How many people
- 440 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2004to 26 Aug 2019
- 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 3 months to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Participants will be selected for inclusion in this study and each to follow on the basis of age, gestational status (i.e., full-term vs. pre-term birth), visual normality, and general health status. Once the recruitment letters have been mailed, a brief screening interview will be conducted with all parents who call to express an interest in participating. These parents will be asked about their infants birth date, expected due date, and any diagnoses of severe perinatal complications, visual abnormalities, and congenital developmental disorders. Infants with a gestational age of less than 36 weeks, and/or those with histories of severe perinatal complications, visual abnormalities, or a family history of color-vision deficiency will not be recruited for participation. Equal numbers of males and females will be recruited to participate.
Who cannot join
None listed.
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: Event Related Potentials From Infancy to Adulthood
This study will explore the development of visual perception and the brain activity that underlies it. It will examine electrical activity in the brain while people are processing characteristics of the visual environment, and how that processing might change with development.
Infants who are within 2 weeks on either side of their 4-month birthday may be eligible for this study. A parent of the child also participates.
Read more
Parents who join the study are asked basic questions about their family, such as its size and ethnic make-up, their infant's birth date, complications of pregnancy or delivery, and any health problems of the infant, such as congenital developmental disorders or visual abnormalities.
Each family is seen at the clinic one time for a 45-minute visit. The infant is outfitted with an elastic net containing many small sensors that make contact with the scalp. He or she is then shown pictures on a computer screen. The sensors in the head net are connected to a computer that records the infant's brain activity while the infant watches the pictures on the screen. The head net is moistened with warm water before being applied, and is not uncomfortable to wear. Towels are available throughout the session to dry any excess moisture from the net.
Read the detailed description
The major objective of this research is to better understand the response of the brain to significant stimulation in early and later development. The proposed work is designed to examine infants', children's, and adults' (especially mothers') responses to salient features of the external environment. To do so, the present research studies the biological bases and behavioral significance of natural preferences and information processing. The primary research strategy to be used consists of analyzing behavioral and brain responses to visual patterns. In a laboratory procedure, subjects will explore patterns and their brain electrical activity will be measured simultaneously with an electronic analysis system. In specific, five experiments of visual attention in human infants, and 1 experiment in adults are proposed. In the first experiment with infants, babies are hypothesized to look longer at more saturated colors; in a second experiment, babies are hypothesized to look longer at gratings aligned along the vertical and horizontal orthogonals than along the obliques. Because saturated colors and orthogonal stimulation elicit greater activity in visual system neurons and greater amplitude evoked potentials than desaturated colors or oblique stimulation, respectively, these two experiments explore the hypothesis that the simple visual stimuli to which infants preferably attend are those that are particularly appropriate in stimulating the geniculostriate or primary visual system. In the third experiment, we plan to trace the ontogeny of the mature brain response to whole patterns as opposed to parts of patterns. In a fourth experiment, we intend to compare region-specific activity when the surface features of a familiarized visual target change to that when its location changes. In the fifth experiment, we examine individual differences in the power metrics associated with attention to visual stimuli in relation to individual differences in their corresponding behavior coded by observers. In an experiment with children and adults we will explore brain responses and their localization in to pictures of familiar and unfamiliar faces.
- Conditions
- Healthy, Child Development
- Keywords
- Behavior and Neurocognition, Functional Brian Activity, Visual Perception, Selective Attention, Information Processing, Age Differences, Childhood Growth and Development, Cognitive Development, Brain Connectivity, Healthy Volunteer, HV
- Medical subject headings
- Behavior
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG response
Measured: Once following enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2004 (estimated)
- Study start28 Jul 2004
- Study completion26 Aug 2019
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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 440 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Clay W. Mash, Ph.D., Principal investigator, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00088712
- Sponsor's protocol ID
- 040250
- Other IDs
- 04-CH-0250
- Status last verified
- 26 Aug 2019
- First submitted
- 30 Jul 2004
- Last updated
- 10 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
Publications
BERLYNE DE. The influence of the albedo and complexity of stimuli on visual fixation in the human infant. Br J Psychol. 1958 Nov;49(4):315-8. doi: 10.1111/j.2044-8295.1958.tb00669.x. No abstract available.
PubMed 13596573Bornstein MH, Arterberry ME, Mash C. Differentiated brain activity in response to faces of "own" versus "unfamiliar" babies in primipara mothers: an electrophysiological study. Dev Neuropsychol. 2013;38(6):365-85. doi: 10.1080/87565641.2013.804923.
PubMed 23971490Mash C, Bornstein MH, Arterberry ME. Brain dynamics in young infants' recognition of faces: EEG oscillatory activity in response to mother and stranger. Neuroreport. 2013 May 8;24(7):359-63. doi: 10.1097/WNR.0b013e32835f6828.
PubMed 23470433
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Event Related Potentials From Infancy to Adulthood
- ClinicalTrials.gov ID
- NCT00088712
- Acronym / sponsor ID
- 040250
- Conditions
- Healthy, Child Development
- Keywords
- Behavior and Neurocognition, Functional Brian Activity, Visual Perception, Selective Attention, Information Processing, Age Differences, Childhood Growth and Development, Cognitive Development
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 440 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- 28 Jul 2004
- Study completion
- 26 Aug 2019
- First posted
- 2 Aug 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.
This study will explore the development of visual perception and the brain activity that underlies it. It will examine electrical activity in the brain while people are processing characteristics of the visual environment, and how that processing might change with development.
Infants who are within 2 weeks on either side of their 4-month birthday may be eligible for this study. A parent of the child also participates.
Parents who join the study are asked basic questions about their family, such as its size and ethnic make-up, their infant's birth date, complications of pregnancy or delivery, and any health problems of the infant, such as congenital developmental disorders or visual abnormalities.
Each family is seen at the clinic one time for a 45-minute visit. The infant is outfitted with an elastic net containing many small sensors that make contact with the scalp. He or she is then shown pictures on a computer screen. The sensors in the head net are connected to a computer that records the infant's brain activity while the infant watches the pictures on the screen. The head net is moistened with warm water before being applied, and is not uncomfortable to wear. Towels are available throughout the session to dry any excess moisture from the net.
Detailed description
The major objective of this research is to better understand the response of the brain to significant stimulation in early and later development. The proposed work is designed to examine infants', children's, and adults' (especially mothers') responses to salient features of the external environment. To do so, the present research studies the biological bases and behavioral significance of natural preferences and information processing. The primary research strategy to be used consists of analyzing behavioral and brain responses to visual patterns. In a laboratory procedure, subjects will explore patterns and their brain electrical activity will be measured simultaneously with an electronic analysis system. In specific, five experiments of visual attention in human infants, and 1 experiment in adults are proposed. In the first experiment with infants, babies are hypothesized to look longer at more saturated colors; in a second experiment, babies are hypothesized to look longer at gratings aligned along the vertical and horizontal orthogonals than along the obliques. Because saturated colors and orthogonal stimulation elicit greater activity in visual system neurons and greater amplitude evoked potentials than desaturated colors or oblique stimulation, respectively, these two experiments explore the hypothesis that the simple visual stimuli to which infants preferably attend are those that are particularly appropriate in stimulating the geniculostriate or primary visual system. In the third experiment, we plan to trace the ontogeny of the mature brain response to whole patterns as opposed to parts of patterns. In a fourth experiment, we intend to compare region-specific activity when the surface features of a familiarized visual target change to that when its location changes. In the fifth experiment, we examine individual differences in the power metrics associated with attention to visual stimuli in relation to individual differences in their corresponding behavior coded by observers. In an experiment with children and adults we will explore brain responses and their localization in to pictures of familiar and unfamiliar faces.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 3 months to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Participants will be selected for inclusion in this study and each to follow on the basis of age, gestational status (i.e., full-term vs. pre-term birth), visual normality, and general health status. Once the recruitment letters have been mailed, a brief screening interview will be conducted with all parents who call to express an interest in participating. These parents will be asked about their infants birth date, expected due date, and any diagnoses of severe perinatal complications, visual abnormalities, and congenital developmental disorders. Infants with a gestational age of less than 36 weeks, and/or those with histories of severe perinatal complications, visual abnormalities, or a family history of color-vision deficiency will not be recruited for participation. Equal numbers of males and females will be recruited to participate.
Key exclusion criteria (0 listed)
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
EEG response
Time frame: Once following enrollment
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 10 Sep 2019.
- Background: PubMed 13596573BERLYNE DE. The influence of the albedo and complexity of stimuli on visual fixation in the human infant. Br J Psychol. 1958 Nov;49(4):315-8. doi: 10.1111/j.2044-8295.1958.tb00669.x. No abstract available.
- Background: PubMed 23971490Bornstein MH, Arterberry ME, Mash C. Differentiated brain activity in response to faces of "own" versus "unfamiliar" babies in primipara mothers: an electrophysiological study. Dev Neuropsychol. 2013;38(6):365-85. doi: 10.1080/87565641.2013.804923.
- Background: PubMed 23470433Mash C, Bornstein MH, Arterberry ME. Brain dynamics in young infants' recognition of faces: EEG oscillatory activity in response to mother and stranger. Neuroreport. 2013 May 8;24(7):359-63. doi: 10.1097/WNR.0b013e32835f6828.
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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.
Clay W. Mash, Ph.D. principal investigator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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 and Child Development, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 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 0 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 10 Sep 2019. 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.
What does the primary outcome measure?
EEG response (time frame: Once following enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00088712, 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 10 Sep 2019.