Nelson Laboratory | Currently Recruiting Studies

Healthy Baby Study

Brief Description
The purpose of this study is to reduce the prevalence of lifelong health impairments that may be caused by stressful experiences in the early years of life. To learn about this we look at the range of experiences that babies have when they are very young, within their first years of life, and see how those experiences affect the way their brain and body develops.

Eligibility for Participation

  • families who have a new baby that is a patient at Children’s Hospital Primary Care Center
  • families whose newborn was delivered at 32 to 36 6/7 weeks gestation and admitted to the NICU following delivery
  • families whose newborn did not have any major complications during NICU admissions

Participation Details
This study involves five visits to our lab, when babies are 2 months, 6 months, 9 months, 12 months, and 24 months old. All of the visits are timed so they coincide with your baby’s primary care visit to help make it very convenient for you to come in. During the visits we ask you to fill out a few questionnaires and we will show your baby some videos while we record their eye movements. We’ll also use a special, non-invasive cap that lets us see their brain activity while they watch the videos. If it’s ok with you we will also collect small saliva and urine samples from your baby and a blood sample from you at each visit. We offer $50 to you per session, so up to $250 in total, as a thank you for participating, as well as a free toy for your baby. We can also provide free parking or transportation and free childcare for siblings.

Research Contact
Call 857-218-3011 or email Healthybabystudy@childrens.harvard.edu

Full Description
It is natural for every family to have a huge range of life experiences (both stressful and non-stressful). For some babies, early stressful experiences have been found to increase risk for health problems later in life. In the current study we aim to understand the range of experiences that babies have, and to determine how different babies respond to those experiences in different ways. To do this we will collect some information from questionnaires, measure a baby’s eye-movements, and record their brain response while they sit on their mom’s lap and watch some fun videos. We will also look at markers in urine and saliva samples from babies and blood samples from moms to see how their bodies respond to the experiences they have had at different points in time.

By using varied methods and following the same babies over their first years, we aim to create a comprehensive picture of risk and resilience during the earliest stages of development. By learning more about how babies respond to the experiences they encounter, we aim to better understand the effects of stress and improve our understanding of which babies are most at risk for health problems later in life. By improving techniques for earlier identification, we aim to create interventions that are best suited to help individual children and their families have the best possible outcomes.


Neural Markers of Fragile X Syndrome

Brief Description
The purpose of this study is to improve our understanding of how differences in brain activity affect learning, language, and behavior in children with Fragile X Syndrome (FXS). Currently there is no effective treatment for FXS and nearly half of all individuals meet criteria for Autism Spectrum Disorder (ASD). Our goal is to find brain markers that predict cognitive, language, and behavioral difficulties in two overlapping neurodevelopmental disorders — FXS and ASD — and to better understand differences in brain activity between children with and without FXS.

Eligibility for Participation

  • Boys or girls 32-84 months old with a diagnosis of Fragile X Syndrome based on full mutation of the FMR1 gene.
  • Boys or girls 32-84 months old with an autism spectrum disorder diagnosis
  • Boys or girls 32-84 months old who are typically developing.

Participation Details
This study involves a single visit to the lab. Each visit will last about 3-4 hours. These visits can be scheduled at your convenience during the day or the weekend.

Research Contact
Email FXSNeuralMarkers@childrens.harvard.edu or call 617-355-4373

Full Description
Fragile X syndrome (FXS) is the most common inherited form of intellectual disability impacting 1 in 4,000 boys and 1 in 6,000 girls. In addition to cognitive deficits, children with FXS often struggle with significant language delays and behavioral challenges, and nearly half of all individuals meet criteria for Autism Spectrum Disorder (ASD). Currently there is no effective treatment for FXS. Animal models of FXS have led to greater understanding of the neurobiology of the disorder, and identified key drug targets that improve cognitive and behavioral phenotypes. Despite extensive research in animal models, only a handful of studies have investigated brain activity and function in children with FXS, presenting a huge roadblock in translating lab-developed therapeutics to patients. This study aims to identify and characterize brain-based markers that predict cognitive, language, and behavioral deficits in young children with FXS and ASD. We will use EEG (a low cost, non-invasive technique) to measure brain activity in response to sensory stimuli, and correlate this with a range of cognitive, language, and behavioral measures. The brain-based markers will then be used in future clinical trials as objective measures for targeted outcomes. Results from this study should improve our understanding of the neural mechanisms that underlie some of the core ASD symptoms and comorbidities seen in FXS.


HEALthy Brain and Child Development Study (hBCD)

Brief Description
Becoming a new mother can be exciting and intimidating, especially when additional health concerns are involved. As part of a greater initiative to end addiction, we hope to better understand substance use disorder in expecting mothers and look to provide better future for all children.

Eligibility for Participation
As a research unit of Boston Children’s Hospital, we invite pregnant mothers, infants and children to help us answer questions of this nature through participation in our research studies. The study is enrolling healthy expecting mothers and healthy infants or children. We are also enrolling expecting mothers struggling with opioid use disorder and infants or children, who may have been exposed to opioids during pregnancy.

Participation Details
Depending on when you or your child begin the study, you will either have one or two visits. The length of the visits also varies based on when you or your child enrolls in the study. If you enroll when you are pregnant, you will have two virtual visits. If you enroll your child in the study, your child will either come in for a visit at 3 months and 6 months of age or once at 3 years of age. If you are interested in participating, we will arrange a time that is convenient for you and your child. During the visits we ask you to fill out a few questionnaires and we will show your baby some videos while we record their eye movements. We’ll also use a special, non-invasive cap that lets us see their brain activity while they watch the videos. We offer $25 to you per session, so up to $50 in total, as a thank you for participating, as well as a free toy for your baby. We can also provide free parking or transportation and free childcare for siblings.

Research Contact
Call 857-218-3011 or email familiesHEAL@childrens.harvard.edu

Full Description
In utero exposure to opioids is causing significant societal concern given the worsening statistics of opioid-related use and abuse in women of child-bearing age. Over the past 2 decades, the rate of opiate usage across the US has increased and the number of newborns with neonatal abstinence syndrome (NAS) has increased. Thus, the opioid crisis represents a constellation of adverse conditions that places the developing child at significantly increased risk for mortality, small gestational growth, preterm delivery, postnatal failure to thrive and worsened neurobehavioral, scholastic, and societal outcomes. Within this project, we will use a battery of behavioral and neuroimaging tools, beginning late prenatal and extending into school age, to examine the effects of opioid and adversity exposure on development.


COVID-19 Supplement - HEALthy Brain and Child Development Study (hBCD)

Brief Description
As part of a greater initiative of the HEALthy Brain and Child Development Study, we now focus our efforts on better understanding stress associated with infection in pregnancy and look to provide better support children born in the time of the current COVID-19 pandemic.

Eligibility for Participation
We invite pregnant mothers both with a positive COVID-19 diagnosis and without a COVID-19 diagnosis to enroll in this study.

Participation Details
All procedures prior to your child’s birth will take place virtually via online surveys. After your child is born, you will have two visits at the Labs of Cognitive Neuroscience at Boston Children’s Hospital. The visits will occur when your child is 3 and 6 months of age. If you are interested in participating, we will arrange a time that is convenient for you and your child. If you are interested in participating, we will arrange a time that is convenient for you and your child. During the visits we ask you to fill out a few questionnaires and we will show your baby some videos while we record their eye movements. We’ll also use a special, non-invasive cap that lets us see their brain activity while they watch the videos. We offer $25 to you per session, so up to $100 in total, as a thank you for participating, as well as a free toy for your baby. We can also provide free parking or transportation and free childcare for siblings.

Research Contact
Call 857-218-3011 or email familiesHEAL@childrens.harvard.edu

Full Description
The COVID-19 pandemic has reached nearly every continent across the globe with a profound impact in the United States. There is limited information regarding the susceptibility of pregnant women to more severe illness, with corresponding implications for their child. While there is uncertainty surrounding the evidence of vertical transmission, the consequential stress of contracting the infection while pregnant may pose a unique set of challenges for new infants and mothers in the current global, national, and local environments. Beyond the physical effects of the illness, contracting the virus during pregnancy is undoubtedly stressful. By using varied methods and following the same babies over their first year, we aim to create a comprehensive picture of how a prenatal COVID-19 diagnosis influences the earliest stages of development.


A Randomized Double-Blind Controlled Trial of Everolimus in Children and Adolescents with PTEN Mutations

Brief Description
The main goals of this study are to determine the safety and efficacy of Everolimus on neurocognitive and social deficits in patients with PTEN. The primary neurocognitive endpoints are working memory, processing speed, and fine motor skills. Currently, there are no effective therapies for individuals with PTEN that targets these core features. Other exploratory objectives include determining the effect of the medication on participants’ microbiome and electroencephalography (EEG) measures. We are also looking into protein biomarkers of PTEN.

Eligibility for Participation

  • Males and females between 5 and 45 years of age with a confirmed PTEN mutation and an IQ at or above 50 are eligible for this study..
  • Patients must also meet a series of safety criteria, which is determined by medical history and some lab work.

Participation Details
This study involves a blinded phase and an open label phase. In the blinded phase, patients will come to the study site 5 times in approximately 6 months. Three of these visits (baseline, month 3, and month 6) will include optional EEG assessments that will be done in the lab. The open label phase is available to participants who receive placebo in the blinded phase. The open label phase will consist of 3 more study site visits, 2 of which will include the EEG assessments. Both phases will have scheduled phone calls so study staff can check in with patients and families. Visits vary in length and can take between 2 and 8 hours. These visits can be scheduled at your convenience during the weekdays.

Research Contact
Email Amelia.Diplock@childrens.harvard.edu, or call 617-919-1476

Full Description
Patients diagnosed with PTEN Hamartoma Syndrome often have cognitive deficits such as language delays, behavioral challenges, and comorbid Autism Spectrum Disorder (ASD). PTEN syndrome is associated with overactivity in the mTOR pathway. For this reason, the study is looking at the effect of Everolimus, an mTOR inhibitor, on the neurocognitive deficits often seen in patients diagnosed with PTEN. The study is hoping to see positive effects of the medication on working memory, processing speed, and fine motor skills.


JASPER Early Intervention For Tuberous Sclerosis Complex

Brief Description
This study will investigate whether a behavioral intervention can improve social communication skills in infants with TSC, with the overarching goal of lessening symptomatology related to ASD. Research has shown that early intervention improves cognitive and behavioral outcomes in children with atypical development. The proposed intervention adapts a parent-mediated intervention that has successfully improved outcomes in toddlers with idiopathic ASD. In addition to testing the primary effects of this early intervention on developmental outcomes of infants with TSC, we also will use electrophysiological (EEG) methods to examine low level visual processing, face processing and resting state EEG oscillations prior to and after intervention.

Eligibility for Participation

  • Infants between 12-36 months of age who have a clinical diagnosis of Tuberous Sclerosis Complex (TSC)
  • English is primary language

Participation Details
Participation requires three visits to the hospital for behavioral assessments before entry into intervention, after exiting intervention, and at a follow up visit. Intervention includes 12-15 weekly intervention sessions. These can be done remotely with the option of coming to the hospital for 4 of these sessions.

Research Contact
Email tscjasper@childrens.harvard.edu or call: (857) 218-3010

Full Description
Infants with Tuberous Sclerosis Complex (TSC) are at high risk for neurodevelopmental disabilities, including autism spectrum disorder (ASD) and intellectual disability (ID). In a recent prospective study of infants with TSC, we found that as early as 6 months of age, infants demonstrated delays in non-verbal behaviors critical for the development of social communication skills, and that by 12 months these delays generalized to both verbal and non-verbal cognition. Moreover, a decline in non-verbal cognition over the second two years of life predicted the development of ASD. Based on this clear evidence of early delays, we propose to investigate whether a behavioral intervention can improve social communication skills in infants with TSC, with the overarching goal of lessening symptomatology related to ASD.