RECRUITING

Mirror Neuron Network Dysfunction as an Early Biomarker of Neurodevelopmental Disorder

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Mirror Neuron Network Dysfunction as an Early Biomarker of Neurodevelopmental Disorder

Quick Facts

Study Start:2018-08-30
Study Completion:2031-02-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03307317

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:9 Months to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * Uncorrected auditory impairment
  2. * Uncorrected visual impairment
  3. * Head injury with loss of consciousness
  4. * Inability to provide consent
  5. * Subject has a condition that in the opinion of the investigator creates an unacceptable risk for participation
  6. * Not being exposed to English as the primary language spoken at home
  7. * 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
  8. * Having a known visual impairment
  9. * Having a known auditory impairment

Contacts and Locations

Study Contact

Maria J Ayoub, Ph.D.
CONTACT
(301) 435-9235
maria.ayoub@nih.gov
Amir H Gandjbakhche, Ph.D.
CONTACT
(301) 435-9235
gandjbaa@mail.nih.gov

Principal Investigator

Amir H Gandjbakhche, Ph.D.
PRINCIPAL_INVESTIGATOR
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  • Amir H Gandjbakhche, Ph.D., PRINCIPAL_INVESTIGATOR, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-08-30
Study Completion Date2031-02-01

Study Record Updates

Study Start Date2018-08-30
Study Completion Date2031-02-01

Terms related to this study

Keywords Provided by Researchers

  • Near Infrared Spectroscopy
  • EEG
  • Functional Brain Activity
  • Neurodevelopment
  • Natural History

Additional Relevant MeSH Terms

  • Developmental Delay