Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT03307317 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Mirror Neuron Network Dysfunction as an Early Biomarker of Neurodevelopmental Disorder

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 512 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor 12 versions Re-verified since Jul 10, 2025, no change to tracked fieldsv501-v512
  2. Minor Study Status, Eligibilityv500
  3. Notable Trial status: Suspended to Recruitingv499 Show 4 more changesShow less
    • Enrollment target: 66 to 200
    • Primary completion date: Aug 1, 2025 to Feb 1, 2030
    • Study completion date: Aug 1, 2025 to Feb 1, 2031
    • Site details revised
  4. Minor 3 versions Re-verified since Mar 1, 2025, no change to tracked fieldsv496-v498
  5. Minor Start date: May 2, 2019 to Aug 30, 2018v495
Show 32 earlier versionsHide 32 earlier versions
  1. Minor 4 versions Re-verified since Sep 7, 2024, no change to tracked fieldsv491-v494
  2. Stopped Trial status: Recruiting to Suspended Sponsor's reason: Premature suspension of the research by the institution due to audit findings.
    • Enrollment target: estimated 200 to confirmed 66
    • Site details revised
    v490
  3. Minor Re-verified, no change to tracked fieldsv489
  4. Minor Study sites: 2 to 1v488
  5. Minor Study sites: 1 to 2v487
  6. Minor 24 versions Re-verified since Jun 7, 2022, no change to tracked fieldsv463-v486
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03307317
Lead Sponsor Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions
(from sponsor)
Developmental Delay
Related terms Learning Disabilities
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov