Trigeminal nerve stimulation for children with prenatal alcohol exposure
This study is testing whether a gentle electric stimulation on the forehead can help children aged 8-12 with ADHD caused by prenatal alcohol exposure feel better and manage their symptoms at home.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 8 Years to 12 Years |
| Sex | All |
| Sponsor | University of California, Los Angeles Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT06847165 on ClinicalTrials.gov |
What this trial studies
This open-label trial investigates the use of trigeminal nerve stimulation (TNS) in children aged 8-12 years who have attention deficit hyperactivity disorder (ADHD) potentially caused by prenatal alcohol exposure (PAE). TNS involves applying a weak electric current to the child's forehead overnight to stimulate the brain, and it is administered at home by parents. The study aims to assess the feasibility of TNS in this specific population, focusing on safety, tolerability, and preliminary efficacy. This is the first time TNS is being evaluated for ADHD associated with PAE, despite its FDA clearance for general ADHD treatment.
Who should consider this trial
Good fit: Ideal candidates are children aged 8-12 years diagnosed with ADHD and confirmed prenatal alcohol exposure.
Not a fit: Patients without a diagnosis of ADHD or those without prenatal alcohol exposure may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for children with ADHD related to prenatal alcohol exposure.
How similar studies have performed: While TNS has shown efficacy in treating pediatric ADHD generally, this specific application for ADHD due to PAE is novel and has not been previously tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Los Angeles, California
- University of California Los Angeles Semel Institute Division of Child & Adolescent Psychiatry — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Joseph O'Neill, PhD — UCLA Division of Child & Adolescent Psychiatry
- Study coordinator: Ishika B Gupta, BS
- Email: ChildBrainStudy@mednet.ucla.edu
- Phone: (310) 267-2710
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.