Actively Recruiting
Trigeminal Nerve Stimulation for Children With Prenatal Alcohol Exposure
Led by University of California, Los Angeles · Updated on 2025-07-01
30
Participants Needed
1
Research Sites
74 weeks
Total Duration
On this page
Sponsors
U
University of California, Los Angeles
Lead Sponsor
N
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Trigeminal Nerve Stimulation for Children With Prenatal Alcohol Exposure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Fetal alcohol syndrome, partial fetal alcohol syndrome, or alcohol-related neurodevelopmental disorder per modified Institute of Medicine criteria
- Prenatal alcohol exposure greater than 6 drinks per week for 2 or more weeks and/or 3 or more drinks on 2 or more occasions during pregnancy
- Diagnosis of ADHD based on DSM-5, confirmed by SNAP IV, MINI-KID, BRIEF II, and Conners 4 assessments
- Parent and child able to complete testing in English
- Child able to cooperate during MRI
- Full-Scale IQ greater than 70 per Kaufman Brief Intelligence Test (K-BIT-2)
- Child able to comply with study procedures
- Age between 8 and 12 years
You will not qualify if you...
- Other toxic exposures clearly more influential than alcohol per clinician judgment
- Known genetic syndromes linked to ADHD-like symptoms such as fragile X, tuberous sclerosis, or generalized resistance to thyroid hormone
- Serious medical or neurologic illnesses likely to affect brain function (e.g., seizures, closed-head trauma)
- Gestation less than 34 weeks
- Contraindications to MRI or TNS such as ferromagnetic metal, claustrophobia, insulin pumps, or other body-worn devices
- Diagnosis of autism spectrum disorder, psychotic disorder, or major mood disorder
- Active suicidal ideation or history of suicide attempts as determined by MINI KID suicidality assessments
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of California Los Angeles Semel Institute Division of Child & Adolescent Psychiatry
Los Angeles, California, United States, 90024
Actively Recruiting
Research Team
I
Ishika B Gupta, BS
CONTACT
J
Joseph O'Neill, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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