View clinical trials related to TSC.
Filter by:The purpose of this study is to use a program called Regulating Together (RT), a remote, non-pharmacologic intervention to treat symptoms of emotion dysregulation in children and adolescents with Tuberous Sclerosis Complex (TSC) and TSC-Associated Neuropsychiatric Disorder (TAND).
The investigators propose a study to adapt an evidence-based caregiver training program to improve access in order to better serve the TSC community. The proposed adapted caregiver training program is based on a targeted behavioral intervention called JASPER (Joint attention, symbolic play, engagement, and regulation) that has successfully improved outcomes in children with ASD. Importantly, JASPER specifically targets two key developmental domains known to be critical for young children with TSC, social communication and play. Recent work with JASPER in children with TSC shows promise, but still requires a commitment to regular in-person sessions. The investigators hope to test an adapted version of the caregiver training version of JASPER, where the entire training is provided remotely through weekly teleconferences and video feedback. The investigators goal is to determine if remote caregiver training can improve social engagement and communication between caregivers and their child with TSC. The investigators hope that by adapting the caregiver training version of JASPER to be delivered through telehealth methods, the investigators can help more families gain access to high quality training. There is a tremendous need for high quality early intervention, and remote caregiver training can give families the skills they need to make impactful and lasting improvements for their child with TSC. The investigators will recruit 66 children, 22 per year whom have been clinically diagnosed with TSC, are 12-36 months of age, English as primary language at home, and have one parent available for weekly remote video conferencing. Participants that meet criteria will be asked to complete assessments from their home (kits will be mailed to them), which will take several sessions (approximately 2.5 hours). During these assessment sessions via Zoom, participants will be shown how to do BOSA, SPACE and CCX assessments. A Vineland and Ages and Stages Questionnaire will also be done during these sessions, but it's just questionnaires. The SPACE and CCX are particulary important because the participants will have to record themselves throughout the study doing these assessments. A brief introduction to JASPER will also be given during this period of assessments. Randomization will occur after assessments are complete. Participants randomized to intervention will need to meet with the research staff for 12 weeks via Zoom to discuss their recorded sessions. Each participant in the intervention group is expected to submit (via UCLA Box) a 30-40 minute video doing JASPER with their child. These videos will be discussed during the Zoom calls. The group not randomized to intervention, will continue to care for their child as usual for those 12 weeks. They will not need to record or meet via Zoom with the research staff. At the end of the 12 weeks, all participants will record themselves doing the two assessments that were taught at UCLA. They will do and record these assessments again 12 weeks after that in the 3-month follow up. The total study is for 6 months.
The primary objective of clinical part of EPISTOP project is to identify the clinical and molecular biomarkers of epileptogenesis in a prospective clinical study of patients with TSC. Secondary objective of the clinical part of EPISTOP is to compare the effects of standard antiepileptic treatment in patients diagnosed as having epilepsy after clinical seizures vs after electroencephalographic epileptiform discharges, in a randomized trial in TSC patients.