Trigeminal nerve stimulation for children with prenatal alcohol exposure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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: Jennifer M Korthas, BS
• Email: ChildBrainStudy@mednet.ucla.edu
• Phone: (310) 267-2710

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Foquest in older adults with ADHD: daily methylphenidate for 65+

  This study tests whether once-daily Foquest helps symptoms in adults 65 and older with ADHD.

  Recruiting Phase 4 Dar Clinical Research Inc. · Ottawa, Ontario · NCT07710014

• Neuroplasticity-targeted supplements for ADHD in children

  A 12-week randomized trial tests whether gut- and brain-targeted supplements can help reduce ADHD symptoms in children aged 6–12.

  Recruiting Khyber Medical University Peshawar · Peshawar, KPK · NCT07665658

• Therapy approaches for irritability in youths: active treatments vs nonactive psychoeducation

  This study tests whether active psychotherapies for irritability in kids aged 8–16.5 years work better than nonactive, time-matched psychoeducation for children and their parents.

  Recruiting National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT07640802

• CARRII Native Intervention Optimization: Finding the Best Online Help for Native Women at Risk of Alcohol-Exposed Pregnancy

  This trial tests different online components of CARRII to see which mix best reduces risk of alcohol-exposed pregnancy among Native women who could become pregnant and drink.

  Recruiting University of Virginia · Charlottesville, Virginia · NCT07547696

• Playful physiotherapy to support children with ADHD or autism

  This program will try a play-based physiotherapy approach to see if it improves emotional, behavioral, and social functioning in Estonian-speaking children aged 5–12 with ADHD or autism.

  Recruiting University of Tartu · Tartu · NCT07466147

• Social cognition testing for 8–16-year-olds with autism, ADHD, or atypical development

  This project will test a multidimensional social-cognition battery in French-speaking 8–16-year-olds with autism, ADHD, or atypical neurodevelopment to see if it better identifies social processing differences.

  Recruiting Assistance Publique - Hôpitaux de Paris · Paris · NCT07439276

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.