TNS-PAENCT06847165

Trigeminal Nerve Stimulation for Children With Prenatal Alcohol Exposure

StatusRecruiting

PhaseNot applicable

SponsorUniversity of California, Los Angeles

Primary completionDec 29, 2026 (estimated)

At risk: Primary completion moved at least 2 months later.

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Record History

All 6 versions: 5 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

Minor Oct 23, 2026 Primary and study completion pushed from Sep 30, 2026 to Dec 29, 2026
- Eligibility criteria expanded, about 15 words
- Site details revised
- Publications: details revised at 2 of 2 entries
Minor Jul 14, 2026 Site contact updatedv5
Notable Apr 28, 2025 Trial status: Not Yet Recruiting to Recruiting
- Start date changed from estimate of Mar 15, 2025 to Apr 26, 2025
- Site details revised
v3
Minor Feb 27, 2025 Start date: Feb 15, 2025 to Mar 15, 2025
- Study description shortened, about 2 words
v2
Feb 20, 2025 Study First Submitted

Notable: the plan changed
Minor: routine updates

Endpoints

Primary

Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale Total Score

Timeframe: administered at baseline and up to 1 week after completing 4 weeks of trigeminal nerve stimulation (TNS) treatment

Secondary (2)

Clinical Global Impression-- Severity (CGI-S) for Attention Deficit Hyperactivity Disorder (ADHD)

Clinical Global Impression-- Improvement (CGI-I) for ADHD

Arms and interventions

Trigeminal Nerve StimulationExperimental

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)

Devices: Trigeminal Nerve Stimulation (TNS)

Sites

1 site in 1 country

University of California Los Angeles Semel Institute Division of Child & Adolescent PsychiatryLos Angeles, California, United States

About this trial

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.

Trial details

Enrollment: 30 participants (estimated)
Started: Apr 26, 2025
Study completion: Dec 29, 2026 (estimated)
Eligibility: 8 to 12, all sexes, no healthy volunteers
Design: Interventional, open label, treatment
Oversight: Data monitoring committee, FDA-regulated device
Conditions: Attention Deficit Disorder with Hyperactivity, Fetal Alcohol Spectrum Disorders, Attention Deficit Hyperactivity Disorder
Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: Feb 26, 2025
Registry updated: Oct 27, 2026
Last verified: Oct 2026

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