CompletedNot Applicable

Event Related Potentials in Infants and Adults

United States440 participantsStarted 2004-07-28

Plain-language 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. 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.

Who can participate

Age range

3 Months – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* INCLUSION CRITERIA: 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

EEG response

Timeframe: Once following enrollment

Trial details

NCT IDNCT00088712

SponsorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Sponsor typeNIH

Study typeOBSERVATIONAL

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