Preventing Epilepsy Using Vigabatrin in Infants with Tuberous Sclerosis Complex (PREVeNT Trial)

We have recently launched a multi-site clinical trial for patients under 6 months of age with a diagnosis of tuberous sclerosis complex (TSC) and no history of seizures. The objective of this study is to compare the developmental impact of early versus delayed treatment with vigabatrin. The results from the trial will help researchers determine if treatment with vigabatrin in TSC infants can prevent or lower the risk of developing infantile spasms or refractory seizures. Study visits allow for close-monitoring and include EEG's and developmental testing. The study is sponsored by the National Institute of Health (NIH).

If you are interested in participating in the study please contact Mia Diplock at 617-919-1476 or amelia.diplock@childrens.harvard.edu.


Longitudinal Study to Identify Early Biomarkers of Autism Spectrum Disorders [Closed to new enrollment]

The goal of this study is to use behavioral testing, MRI and EEG techniques to identify early signs of autism in children with TSC. Eligible infants between the ages of 3-9 months will be followed and evaluated at regular visit intervals up to 3 years of age.  Throughout the study, we will recommend Early Intervention services and assist in obtaining referrals for any child who shows early signs of autism. At the end of the study we will also provide a summary report for all testing that was done. Limited travel funding may be available for out of state participants. Additional information about the study is available at www.tscstudy.com

For more information about this study or if you are interested in participating, please contact study coordinator Erin Carmody at erin.carmody@childrens.harvard.edu or 617-919-4599.

To download the study flyer, please click here.

Potential EEG biomarkers and antiepileptogenic strategies for epilepsy in TSC  [Closed to new enrollment]

This research study aims to learn more about early changes in brain patterns in infants with tuberous sclerosis complex (TSC) to see if these changes can predict future seizures. Information gained from this study will be used to better understand the brain pattern changes that happen before the onset of epilepsy as well as the time between those pattern changes and the start of seizures. Infants up to 6 months old with TSC and with no history of seizures may be eligible to participate. Eligible infants will be followed for approximately 2 years after enrollment. Limited funding will be available for out of state patients. Additional information about the study is available at www.tscstudy.com.

For more information about this study,  please contact study coordinator Kira Dies at kira.dies@childrens.harvard.edu or 617-919-3009.

To download the study flyer, please click here.

Early Screening for Autism in the Tuberous Sclerosis Complex (TSC)  [Closed to new enrollment]

We are currently conducting a study at Boston Children’s Hospital and University of California, Los Angeles for individuals diagnosed with Tuberous Sclerosis Complex (TSC) who are between the ages of 3 months and 3 years. The main goal of this research project is to look for early signs of autism in children with TSC. Up to 60% of children with TSC develop autism, but the diagnosis typically is not made until much later in childhood. Early detection leads to earlier interventions and, hopefully, better behavioral outcomes. We hope that the knowledge gained from this investigation will ultimately lead to earlier diagnosis of autism in infants with and without TSC. We hope to follow each infant for a few visits at either Boston Children’s Hospital or University of California, Los Angeles over his or her first 3 years of life. Scheduling of these visits is very flexible and based on your needs. Study visits include behavioral measures, event-related potentials (ERPs), an MRI, a neurological exam, and an ambulatory EEG. A subset of these measures is conducted at each visit. There is no fee to participate in this study. Families will be compensated for their time, and travel and parking are fully covered. Children will also receive a small toy at the end of each visit to the lab. During the testing, if we detect any abnormalities that may warrant further interventions, you will be notified. After all data has been analyzed, families will be informed of the overall results of the study. Enrollment in this research study began in June 2011 at both sites. Interested out-of-state families are welcome to participate at either the Boston or Los Angeles site, and compensation may be available for travel costs.

To download the study flyer, please click here.

For more information about this study, please send an email to tsc.development.study@gmail.com or call 617-678-7348.