Trigeminal Nerve Stimulation for Children With Prenatal Alcohol Exposure

NCT ID
NCT06847165
Registry status
Recruiting
Study type
Interventional
Phase
Not applicable
Sponsor
University of California, Los Angeles
Conditions
Attention Deficit Hyperactivity Disorder, Fetal Alcohol Spectrum Disorders

Overview

ClinicalTrials.gov lists this study as Recruiting.

Enrollment: 30 participants (Estimated).

What is being studied

  • Device: Trigeminal Nerve Stimulation (TNS)

Who may be eligible

Ages
8 Years to 12 Years
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following 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

Study locations

1 study location is listed.

Recruiting site status is explicitly provided for 1 location; 1 is listed as Recruiting.

Countries: United States

  • California, United States: 1

Sample of listed locations

  • University of California Los Angeles Semel Institute Division of Child & Adolescent Psychiatry — Los Angeles, California, 90024, United States — Recruiting

Study details

Start date
April 26, 2025
Primary completion date
September 30, 2026
Completion date
September 30, 2026
First posted
February 26, 2025
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT06847165
Registry last updated
July 16, 2026
QualifiedStudies registry data refreshed
September 28, 2026
QualifiedStudies record fetched
September 28, 2026

View NCT06847165 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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