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RECRUITING

NCT06847165

Trigeminal Nerve Stimulation for Children With Prenatal Alcohol Exposure

Sponsor: University of California, Los Angeles

View on ClinicalTrials.gov

Summary

This is an open-label trial of trigeminal nerve stimulation (TNS) for children aged 8-12 years with attention deficit hyperactivity disorder (ADHD) putatively due to prenatal alcohol exposure (PAE). TNS has been successful in treating pediatric ADHD generally and it is US Food and Drug Administration (FDA)-cleared for this condition. But this will be the first time it is tried for ADHD specifically associated with PAE. In TNS, a weak electric current is applied to the child's forehead overnight while sleeping to gently stimulate the brain. TNS is administered at home by the parent to the child. TNS is safe and well tolerated. Efficacy of TNS in ADHD is \~50%. The purpose of the present pilot study is to determine the feasibility of TNS for children with PAE and ADHD. Feasibility means safety (any serious side effects?), tolerability (do children comply with TNS? are they comfortable with it?), and a rough idea of efficacy (does TNS seem to work in most kids?) A secondary goal of the study is to get a more precise idea of brain mechanisms of TNS with magnetic resonance imaging (MRI). Families who participate will make three clinic visits: eligibility (4-5 hours), pre-TNS (2-3 hours including MRI), and post-TNS (2-3 hours including MRI). Children will receive TNS, applied by the parent, for 8 hours every night while sleeping for 4 weeks. Four weeks after treatment, families will take part in a telephone follow-up, to see whether any improvements made last.

Key Details

Gender

All

Age Range

8 Years - 12 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-04-26

Completion Date

2026-09-30

Last Updated

2025-07-01

Healthy Volunteers

Conditions

Fetal Alcohol Spectrum Disorders Attention Deficit Hyperactivity Disorder

Interventions

DEVICE

Trigeminal Nerve Stimulation (TNS)

In TNS, a weak electric current is applied to the child's forehead overnight while sleeping to gently stimulate the brain. TNS treatment is typically administered at home at bedtime by the parent to the child. The TNS device is small (size of a cell phone) and easy to use. Two thin wires go from the device to a pair of small electrodes that tape onto the forehead like a band-aid. The parent presses three keys on the device and it is ready to go.

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

Locations (1)

University of California Los Angeles Semel Institute Division of Child & Adolescent Psychiatry

Los Angeles, California, United States