An interventional study of Trigeminal Nerve Stimulation (TNS) in Fetal Alcohol Spectrum Disorders and Attention Deficit Hyperactivity Disorder, sponsored by University of California, Los Angeles. Recruiting at 1 site in United States. Open to participants aged 8 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-07-16.
Sponsored by University of California, Los Angeles · Not applicable, Interventional, and Treatment
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.
Trigeminal nerve stimulation (TNS) is a new treatment for pediatric ADHD developed at University of California Los Angeles (UCLA). 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. TNS is safe and well tolerated. The success rate, or efficacy, of TNS is about 50% in children with ADHD overall. Although TNS is FDA-cleared for children with ADHD, regardless of the cause, or etiology, of the ADHD, the possible influence of etiology on TNS success has not yet been studied. One common etiology of ADHD is prenatal alcohol exposure (PAE). When a mother drinks alcohol during pregnancy her child often develops ADHD. While TNS is an approved treatment for these children, it is actually not known whether they would respond any differently. It is known that drug treatments that routinely work well in children with ADHD without PAE are poorly effective in many children with ADHD due to PAE. Thus, there is a chance children with ADHD due to PAE could respond differently (better or worse) to TNS as well. The purpose of the research is to determine the safety and efficacy of TNS specifically in children whose ADHD is associated with PAE. We expect that TNS will be as safe and effective in children with ADHD with PAE as in children without, but that needs to be formally tested. As a first step in the formal testing process, this pilot study aims to determine the feasibility of TNS in children with ADHD associated with PAE. 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 our study is to get a more precise idea of where and how TNS acts in the brain using MRI-based neuroimaging. Families who participate in the study will come to the clinic for three visits: eligibility (4-5 hours), pre-TNS (2-3 hours including MRI), and post-TNS (2-3 hours including MRI). Thus, the child will undergo two MRIs of the brain, a safe, non-invasive, and radiation-free procedure. The child will receive TNS treatment, 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.
63 studies on the registry are indexed under Fetal Alcohol Spectrum Disorders; 13 are open to participants now.
This study's planned enrollment of 30 is below the median of 70 across 55 interventional studies indexed under Fetal Alcohol Spectrum Disorders.
Browse Fetal Alcohol Spectrum Disorders studies →University of California, Los Angeles is the lead sponsor of 1,142 studies on the registry; 192 are open to participants now.
Of its 91 completed or terminated interventional studies of FDA-regulated products, 66 (73%) have results posted.
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Exclusion Criteria:
Each child will receive nightly trigeminal nerve stimulation, administered by the parent at bedtime, for 8 hrs while sleeping overnight, nightly for 4 weeks (28 days)
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.
Also known as: external trigeminal nerve stimulation
Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale Total Score
clinician-administered measure of severity of core ADHD symptoms: inattention and hyperactivity/impulsivity; minimum score 0, maximum score 40, a higher score means a worse outcome
Time frame: administered at baseline and up to 1 week after completing 4 weeks of trigeminal nerve stimulation (TNS) treatment
Clinical Global Impression-- Severity (CGI-S) for Attention Deficit Hyperactivity Disorder (ADHD)
This is clinician-administered measure of overall severity of ADHD symptoms: minimum score 1, maximum score 7; higher score is worse outcome
Time frame: administered at baseline
Clinical Global Impression-- Improvement (CGI-I) for ADHD
CGI-I: minimum score 1, maximum score 7; higher score is worse outcome
Time frame: administered up to 1 week after completing 4 weeks of trigeminal nerve stimulation (TNS) treatment
Plan to share: Yes — Trial data will be posted to the National Institute on Alcohol Abuse and Alcoholism (NIAAA) Data Archive
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Fetal Alcohol Spectrum Disorders→
University of California, Los Angeles