A pilot study of vagus nerve stimulation (VNS) for autonomic dysregulation in individuals with the developmental disabilities

This study is examining whether a non-invasive device called vagus nerve stimulator (VNS) improves symptoms related to intellectual and developmental disability (IDD) and/or autism spectrum disorder (ASD). VNS involves applying mild electrical stimulation through the skin around the neck. The vagus nerve sends communications between the brain and many parts of the body. It regulates many cognitive, emotional and bodily functions. VNS is FDA-approved for headaches in people 12-years and older.

What are the goals of the study?

The purpose of the study is to examine whether a device called vagus nerve stimulator (VNS) can help with autonomic symptoms commonly seen in developmental disabilities, including autism.

What will happen during the visit or online?

The participant will undergo several behavioral, neurocognitive, and EEG tests and attend regularly scheduled study appointments. The study duration will be between 9-11 months, which includes 1, 3, 6-month follow-up appointments.

How will this help families?

Possible improvements in some symptoms related to developmental disabilities and ASD with the use of VNS.

Researchers in Baltimore, MD at Johns Hopkins University and Kennedy Krieger Institute are interested in investigating the underlying neural mechanisms associated with perceiving social interactions. We are recruiting adults (ages 18-35 years) with and without autism. Participation in this study includes a 90–120-minute MRI scan, a 10-minute recall task, a 30-minute IQ assessment, and six questionnaires. Participants with autism will also be asked to complete a 1-hour interview. Participants will be compensated with a $60 VISA gift card at the end of their research appointment.

What are the goals of the study?

The purpose of this study is to investigate the feeding difficulties of infants who are later diagnosed with autism compared to their neurotypical sibling to identify any feeding characteristics that would warrant increased monitoring for autism in infancy.

What will happen during the visit or online?

Completion of a 90-120-minute MRI scan, brief questionnaires, 10-minute recall task and 30-minute IQ assessment

How will this help families?

We are investigating the neural mechanisms underlying perceptions of social interactions which will enable researchers to develop better informed therapies and trainings focused on social skills acquisition

An eye-tracking study to learn more about how Spanish-English bilingual adults with autism process language in real time. Participants will complete questionnaires, language proficiency tasks, and computer-based tasks — responding with button presses on the keyboard while their eye movements are tracked. The study will take one hour over one session. Given the large number of bilinguals both worldwide and in the US, this study aims to shed light on the important question of how language skills in ASD impacted by speaking another language.

What are the goals of the study?

We hope to better understand how Spanish-English bilingual adults with autism process language in real time.

What will happen during the visit or online?

Eye-tracking study

How will this help families?

Families affected by autism are often recommended by pediatricians, educators, and speech therapists to focus on the language of schooling and refrain from using the family’s home language. While bilinguals are underrepresented in ASD research, there is emerging evidence that exposure to a second language does not negatively impact language skills in children with ASD. This study hopes to shed more light on this question and help families make better informed decisions regarding raising their child with ASD in a bilingual environment (or not).

We are a team of researchers located at the MGH Institute of Health Professions (MGH IHP) in Boston, MA. We are completing a study about speech therapy treatment for children with the motor speech disorder childhood apraxia of speech and autism. Instead of being primarily drill-based, therapy will be embedded in a social, play-based context to provide ecologically valid feedback and help children generalize their skills as much as possible.

What are the goals of the study?

The main aim of this study is to test whether treatment for the motor speech disorder childhood apraxia of speech, appropriately modified for minimally verbal autistic children, does in fact improve speech production in minimally verbal children with both conditions.

What will happen during the visit or online?

Prospective participants will be assessed in our lab in Charlestown with a variety of measures that document their speech, language, social, and nonverbal IQ skills. During the speech tasks only (estimated to last approximately 30 minutes), children will wear reflective markers, 2-3 millimeters in size, on their faces. Our multiple camera system will track the movements of these markers as children attempt to repeat a series of syllables and simple words. Baseline assessments are conservatively estimated to last approximately 4 hours, scheduled as two 2-hour visits. All assessments will be audio- and videotaped for later analysis.

During the baseline visits, children’s parents will also be asked to complete a series of questionnaires that document demographics, developmental history, and current levels of community functioning.

After analysis of baseline data (documenting that participants meet criteria for ASD, minimally verbal status, and CAS), children who meet inclusion criteria will be invited to receive treatment. A set of 6 one- or two-syllable words will be selected for each child, identified from their baseline tests to specifically involve the speech movements that are found to be disordered in their speech (i.e., stimuli will consist of words that the child can attempt to say but which are not pronounced perfectly).

Treatment will consist of 15 hour-long sessions over 3 weeks and may take place in our lab or at a child’s home or school, and will be video- and audio-recorded for later analysis.

During treatment sessions, children will practice each target multiple times, divided into separate practice blocks and interspersed with practice on the other targets. A “scaffolding” hierarchy will be employed to help children learn the correct speech movements for each target. Specific scaffolding activities that the therapist will provide include (1) producing the target slowly, (2) producing it in unison with the therapist, (3) gradually fading out this assistance as the child learns to produce the targets correctly on their own, and (4) providing tactile or visual cues to help children remember the correct oral movements for each target.

Practice will occur in a naturalistic, developmentally-informed framework, which involves embedding speech tasks within social interactions organized around play or social activities that are matched to the child’s developmental level and that incorporate the child’s target words. For example, if a child has difficulty saying the consonant /k/, the word “cookie” might be selected as a target. This word could be practiced during an activity where therapist and child pretend to feed a stuffed animal cookies or where they actually decorate and eat cookies as a snack. The aim is for children to learn correct speech production at the same time that they engage in positive and rewarding social interactions that promote skill generalization, rather than for them to simply respond to therapist prompts.

After treatment is completed, children will be invited back to the lab to have their speech production analyzed, using the same procedures as at baseline. They may also re-enroll to receive an additional series of 15 treatment sessions if desired.

For their time, participants will receive $50 for completion of the baseline testing and $100 upon completion of the post-treatment testing. Parking compensation will be provided for each visit to our Charlestown lab location.

How will this help families?

In our research, we are interested in understanding why many children with autism don’t learn to talk on their own. Our ultimate goal is to improve communication outcomes for children at risk for being minimally verbal. In this study, participants will be contributing to the advancement and development of evidence-based speech treatment approaches for children with autism and childhood apraxia of speech.

This study is being completed by a team of health researchers from the SPAN (Speech in Autism and Neurodevelopmental Disorders) Lab at the MGH Institute of Health Professions (MGH IHP) in Boston, MA. In this study, we want to understand how minimally and low-verbal autistic children perceive speech sounds, and then to see if that is related to their own speech production and expressive language abilities.

What are the goals of the study?

We hypothesize that, if some kids can’t hear the difference between similar-sounding words like “ball” and “doll”, maybe they can’t learn to pronounce words accurately and this interferes with their being able to learn spoken language.

What will happen during the visit or online?

We created a tablet-based video game to help us answer these questions, where children sort pictures into categories. It includes a purely visual version of the task as well as an auditory version, so that we can tell if children have auditory processing issues only or whether their challenges also extend to visual stimuli.

Prospective participants will be assessed in our lab in Charlestown, MA with a variety of measures that document their speech, language, social, and nonverbal IQ skills. They will then be given the tablet game to play. The visits will be broken down into two 2-hour visits. All assessments and game play will be audio-and videotaped for later analysis.

During the visits, children’s parents will also be asked to complete a series of questionnaires that document demographics, developmental history, and current levels of community functioning. Parents will also be asked to participate in an hour-long interview either in person or by zoom, whichever is most convenient for the parent.

For their time, participants will receive $25 for completion of the assessments and will get an additional sum of $50 once they have completed the whole study. Parking compensation will be provided for each visit to our Charlestown lab location.

How will this help families?

In our studies, we are interested in understanding why many children with autism don’t learn to talk on their own. Participation in this study would help our researchers better understand auditory perception in children with autism with the ultimate goal being to improve communication outcomes for children with autism at risk for being minimally verbal.

This research study aims to find out more about adults with autism spectrum disorder, including how adults with autism think, how their brains work, and how these things change as they get older.

What are the goals of the study?

The main goal of the study is to understand the aging process in people with autism.

What will happen during the visit or online?

The study involves autism diagnostic evaluation at the SDSU Center for Autism, and a neuropsychological battery testing the individual’s memory, attention span, and other cognitive skills. Participants are also asked to undergo an MRI scan at the SDSU Imaging Center, which allows us to collect information about the brain anatomy and function. Because we are aiming to understand how people with autism age, we hope to repeat this evaluation in about 3-5 years, inviting participants to return for another scan and a set of assessments.

How will this help families?

Participants in this study report that they learn important information about their memory and other cognitive abilities from participating in the study. Broadly, the results of this study should help us understand how people with autism age – something that has not been studied nor well understood thus far.

Six-to-ten year old children with autism spectrum disorders are invited to participate in a fun study, which involves wearing an actigraphy watch for two weeks (to estimate the quality and other characteristics of the child’s sleep) and participation in one MRI session at SDSU Imaging Center. Both children and parents are asked to keep sleep diaries for the two weeks when the child is wearing the actigraphy watch. Finally, children are asked to take part in a brief cognitive testing session. The study aims to understand the links between sleep (problems) and brain development in children with autism.

What are the goals of the study?

This study aims to understand potential mechanisms underlying sleep disturbances in autism.

What will happen during the visit or online?

Children will be asked to wear an actigraphy watch for two weeks, keep sleep diaries, take part in one MRI scan, and complete a brief behavioral assessment session.

How will this help families?

Sleep problems affect 50-80% of individuals with autism and can have cascading effects on development, everyday function, and quality of life. However, the mechanisms underlying sleep disturbances in ASD are not understood. A better insight into the potential mechanisms of sleep disturbances in autism may ultimately help with developing new treatments targeting sleep in children with autism.

Researchers at Seattle Children’s are looking for caregivers of 2 to 12 year old children without autism spectrum disorder or challenging behaviors (e.g., aggression, destruction) that require intervention to take part in an online survey study and an optional in-person EEG visit. Parents will be compensated with a $50 gift card for completing the questionnaires and a $50 gift card for completing the in-person visit.

What are the goals of the study?

The goal of this study is to study parent and child problem-solving and emotions in an intervention that includes parents.

What will happen during the visit or online?

Parents will complete an online survey (about 30 minutes) about their and their child’s problem-solving and emotions and in a one-time in-person EEG and cognitive visit that includes problem-solving and other tasks.

How will this help families?

The study is being done to learn more about parents’ emotion and mental processes.

In this study, we will present a series of validated eye tracking paradigms (e.g., images of faces, videos of social interactions) while we monitor eye movements and physiological arousal. Two research assistants will also collect behavioral reports of ASD and ADHD symptoms from 8-12 years old participants. These data will allow us to examine how and if eye movements, arousal, and questionnaire outcomes differ between children with ASD and ADHD. By combining eye tracking/arousal measures and behavioral assessments, we will then draft a map of how these social cognitive traits manifest in eye movements.

What are the goals of the study?

The primary aim of this study is to test the utility of a social cognitive battery incorporating psychophysiological measures to differentiate between autism spectrum disorder (ASD) and attention-deficit/hyperactivity disorder (ADHD).

What will happen during the visit or online?

A brief telephone screening will be conducted to determine if the child and family are interested in the study. Then, a research team member will schedule a time for the family to come into the lab for approximately 90 minutes. Prior to the visit, parents will be asked to send a copy of a recent diagnostic assessment to confirm diagnosis. During the visit, the participant will come to our lab with their parent. Upon completion of the consent and assent, cognitive screener will be conducted first to the child and then the eye tracking tasks will be administered using the Eyelink 1000. We will ask the child to sit in front of a computer screen, and we will be showing the child some videos and images while the computer will track the child’s physiological response and their eye movements. Parent and caregivers will complete a few questionnaires by the time. Upon completion of all measures, the participant will be given a $20 gift card for their time.

How will this help families?

Families will receive a feedback summary compiling information regarding their responses on questionnaires, including the Conners, SRS, and CBCL. Families will learn about their children’s current condition in behavior performances and cognitive development. If requested by contacting the lab via phone or email (or indicating during the study visit), a 15 minute phone feedback session will be scheduled for the parents with the PI, clinical psychologist, to discuss the results from the questionnaires. This will also offer the PI a chance to address any other questions the parents may have. Participants will also be compensated $20 for their time.

This is a research study to learn more about how children learn to understand language, and the role that caregivers play in this process. By learning more about these processes, we may be able to contribute to a better understanding of language development and impairment and the design of more effective intervention programs and therapies to support language learning. This study will be conducted by Dr. Sudha Arunachalam of the Communicative Sciences and Disorders department at the Steinhardt School of Culture, Education, and Human Development, New York University, and Dr. Rhiannon Luyster of the Communicative Sciences and Disorders department at Emerson College.

What are the goals of the study?

Learn more about how children learn to understand language, and the role that caregivers play in this process.

What will happen during the visit or online?

If you give permission for your child to participate in this study, your child will be asked to play some games with us in the lab at 665 Broadway in Manhattan, and have a play session at home over web camera on your computer or tablet via Zoom videoconferencing software. You will be with your child the entire time. The in-person study is schedule for 1.5 hours, and the Zoom conferencing part of the study will take approximately 30-45 minutes of you and your child’s time.

The study also involves online surveys that can be completed by you from any location on a desktop, laptop, or tablet computer. These surveys will focus on your child’s demographics, daily activities, and language use, and will take up to 30 minutes to complete.

How will this help families?

We may be able to contribute to a better understanding of language development and impairment and the design of more effective intervention programs and therapies to support language learning.

Dr. Eggebrecht and researchers at Washington University in St. Louis are mapping brain function in children with autism spectrum disorder with diffuse optical tomography.

What are the goals of the study?

Dr. Eggebrecht and researchers at Washington University in St. Louis aim to investigate brain function underlying development in children who have or are at risk for developing Autism Spectrum Disorder.

What will happen during the visit or online?

Children will complete a 1-hour brain imaging scan and developmental testing at Washington University School of Medicine in St. Louis. Parents will complete online and phone surveys from home. Families will be compensated $25/hour for their participation.

How will this help families?

We hope that, in the future, society may benefit from study results which increase our understanding of typical and altered development of brain function. We hope that in the future, optical imaging will complement the current brain imaging technologies in the management of a variety of patient populations.

This pediatric autism clinical research study is currently testing the drug, pimavanserin, to see if it is safe and effective in treating irritability and other behaviors in children and adolescents with autism spectrum disorder (ASD). Study participation will last for up to 14 weeks, with a 6-week treatment period. Children who enroll in this study will receive either the study drug or placebo. A placebo looks like the study drug but has no impact on the person taking it. There will be no cost for the study drug or any study-related procedures. You may be compensated for your time and travel. If your child completes the 6-week treatment period, they may be able to enroll in a 52-week, open-label extension study if they qualify. During this open-label study, there is no placebo. Children who enroll will receive the study drug, pimavanserin.

What are the goals of the study?

The overall goal of this study is to evaluate whether an investigational drug might help relieve irritable behaviors associated with Pediatric Autism Spectrum Disorder that make social interactions and everyday functioning challenging.

What will happen during the visit or online?

Study participation will last for up to 14 weeks, with a 6-week treatment period. Children who enroll in this study will receive either the study drug or placebo. A placebo looks like the study drug but has no impact on the person taking it. There will be no cost for the study drug or any study-related procedures. You may be compensated for your time and travel.
If your child completes the 6-week treatment period, they may be able to enroll in a 52-week, open-label extension study if they qualify. During this open-label study, there is no placebo. Children who enroll will receive the study drug, pimavanserin.

How will this help families?

The evaluation of this investigational drug may help relieve irritable behaviors associated with Pediatric Autism Spectrum Disorder that make social interactions and everyday functioning challenging.