Mirror Neuron Network Dysfunction as an Early Biomarker of Neurodevelopmental Disorder (NCT03307317) | Clinical Trial Compass
RecruitingNot Applicable
Mirror Neuron Network Dysfunction as an Early Biomarker of Neurodevelopmental Disorder
United States200 participantsStarted 2018-08-30
Plain-language summary
Background:
People show changes in brain activity when they watch other people do actions. This may be part of early social and communication skills. Researchers want to understand the stages of normal development of motor observation and imitation in people and how it relates to social development in infants and toddlers.
Objective:
To study the nature of brain activity that underlies typical brain functioning in infants, toddlers, and adults.
Eligibility:
Infants ages 8 12 months
Healthy adults ages 18 65
Design:
Adult participants will have one visit. They will:
Answer questions about their family, like its size and ethnicity.
Answer questions about their own behavior and do a simple motor task.
Have EEG/fNIRS. A damp elastic cap with small sensors will be placed on the head. Participants will observe stimuli, either on a video screen or of a live person. The sensors will be connected to a computer. That will record the participant s brain activity while watching pictures on a screen.
Infant participants will have 2 visits.
Their parents will answer questions about their family.
The parents will fill out forms about their child s development. These will be mailed to them before each visit.
Parents will stay with their infant while study staff does an assessment of the child s communication, motor, and thinking skills.
Infants will have EEG/fNIRS.
Infants who are at risk for developmental delays will come back for another visit when they are about 2 years old. This will repeat the infant visits but it will not include EEG/fNIRS.
Some questionnaires and assessments will be videotaped.
Who can participate
Age range
9 Months – 65 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 CRITIERIA:
Healthy adults
* Age of 18-65 at study entry
* Healthy and good condition as determined by medical history and physical examination
Healthy Infants
* 9 months +/- 2 weeks of age at time of consent
* Healthy and good condition as determined by medical history and physical examination
* Age appropriate development as determined by parent report and exam
* Full term at birth
* Normal weight for gestational age
At Risk Infants
* 12 months +/- 2 weeks at the time of consent
* Must have at least one of the following: observed developmental delay; sibling of a child with autism; premature birth; small for gestational age
EXCLUSION CRITERIA:
Healthy Adults
* Uncorrected auditory impairment
* Uncorrected visual impairment
* Head injury with loss of consciousness
* Inability to provide consent
* Subject has a condition, that in the opinion of the investigator, creates an unacceptable risk for participation
Healthy and At-Risk Infants
* A language other than English as the primary language spoken at home
* Having a medical impairment that interferes with study participation such as having a g-tube, shunt or seizure disorder and inability to hold one s head upright
* Having a known visual impairment
* Having a known auditory impairment
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
1
Developmental level
Timeframe: Visit 2 for AR group
2
Hemodynamic response function and mu suppression
Timeframe: Visit 1 for Adult Pilot, TD and AR infants; visit 2 for TD infants
Trial details
NCT IDNCT03307317
SponsorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)