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New treatment option for TSC
Official title Regulating Together in Tuberous Sclerosis Complex
ClinicalTrials.gov ID: NCT06105736
What this study is testing
- What it's testing
- 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).
- Time commitment: about 5 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 8 to 17
You may be able to join if
- Children ages 8-17 years inclusive with a documented clinical and/or genetic diagnosis of TSC and exhibiting symptoms of behavioral dysregulation...
- Participants and their caregivers have access to a computer, phone, or tablet with video capability and stable internet connection. If lack of a...
- Participants must also be willing to participate in treatment sessions and have minimal levels of functional verbal communication (child and their...
- Child must have a minimum IQ\>65 on the WASI-II at the screening/baseline visit).
You likely can't join if
- Participants be on a stable medication regimen at least 4 weeks prior to enrollment
- Do not have a plan to start a new psychosocial intervention (e.g., individual psychotherapy, family psychotherapy, group psychotherapy or social...
The study team makes the final eligibility decision.
Where it's taking place
- Carrboro, North Carolina, United States
- Cincinnati, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 5 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 8 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Carrboro, North Carolina, United States; Cincinnati, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.