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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