Trigeminal Nerve Stimulation for Children With Prenatal Alcohol Exposure

Launched by UNIVERSITY OF CALIFORNIA, LOS ANGELES · Feb 20, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a treatment called trigeminal nerve stimulation (TNS) for children aged 8 to 12 who have attention deficit hyperactivity disorder (ADHD) potentially caused by prenatal alcohol exposure. TNS involves gently applying a small electric current to the child's forehead while they sleep, which has previously shown promise in treating ADHD in children. This is the first time TNS will be specifically tested for children with ADHD related to prenatal alcohol exposure. The study aims to see if TNS is safe and comfortable for these children and to get an idea of how effective it might be.

To participate, children must have been diagnosed with fetal alcohol spectrum disorders and ADHD, and their mothers must have consumed alcohol during pregnancy. Families will need to attend three clinic visits for testing and monitoring, and the children will use the TNS device every night for four weeks. After the treatment period, there will be a follow-up phone call to check on any improvements. It's important to note that the trial is not yet recruiting participants, but it is a unique opportunity for families dealing with the challenges of ADHD related to prenatal alcohol exposure.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • - Fetal alcohol syndrome, partial fetal alcohol syndrome, or alcohol-related neurodevelopmental disorder per modified Institute of Medicine criteria (thus positive maternal drinking in pregnancy required, facial stigmata not required)
• • Prenatal alcohol exposure (PAE) \>6 drinks/week for \>= 2 weeks and/or \>= 3 drinks on \>= 2 occasions throughout gestation per Health Interview for Women/Health Interview for Adoptive and Foster Parents (HIW/HIAFP)
• • Diagnosis of Diagnostic and Statistical Manual 5th edition (DSM-5) attention deficit hyperactivity disorder (ADHD), including problems with inattention, hyperactivity, impulsivity, and/or executive function. Screening for ADHD will be done using the Swanson, Nolan, and Pelham Teacher and Parent Rating Scale (SNAP IV). Formal diagnosis of ADHD will be based on the Mini-International Neuropsychiatric Interview for Children and Adolescents (MINI-KID) with input from the Behavior Rating of Executive Function (BRIEF II) and the Conners 4.
• • Parent and child able to complete testing in English
• • Child able to cooperate during MRI
• • Full-Scale Intelligence Quotient \>70 per the Kaufman Brief Intelligence Test (K-BIT-2)
• • Child able to comply with study procedures
• • Age 8-12
• Exclusion Criteria:
• • - Other toxic exposure per HIW/HIAFP whose influence clearly surpasses that of alcohol (very rare) per study clinician judgement
• • Known genetic syndrome associated with ADHD-like symptoms including fragile X, tuberous sclerosis, or generalized resistance to thyroid hormone
• • Serious medical or neurologic illness likely to influence brain function, e.g., seizures, closed-head trauma
• • Gestation \< 34 weeks
• • Ferromagnetic metal, claustrophobia, or other MRI or TNS contraindication (e.g., insulin pumps or other body-worn devices)
• • Diagnosis of autism spectrum disorder, psychotic disorder, or major mood disorder
• • Active suicidal ideation as evidenced by meeting criteria for "Current" or "Lifetime attempt" on the Suicidality module or "Current' or 'In early remission' on the Suicide Behavior Disorder module of the MINI KID