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NCT06847165 · ClinicalTrials.gov registry record · NA

Trigeminal Nerve Stimulation for Children With Prenatal Alcohol Exposure

A NA study of Attention Deficit Hyperactivity Disorder and Fetal Alcohol Spectrum Disorders, sponsored by University of California, Los Angeles.

Recruiting
Registry status
NA
Development phase
30
Enrollment target
1
Study location

NCT06847165: Recruiting NA study of Attention Deficit Hyperactivity Disorder and Fetal Alcohol Spectrum Disorders, sponsored by University of California, Los Angeles.

NCT06847165 is a NA study of Attention Deficit Hyperactivity Disorder and Fetal Alcohol Spectrum Disorders that is actively recruiting participants, run by University of California, Los Angeles. The registered enrollment target is 30 participants, below the 216-participant average among 102 other Attention Deficit Hyperactivity Disorder trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06847165, a NA study of Attention Deficit Hyperactivity Disorder and Fetal Alcohol Spectrum Disorders, is actively recruiting participants, sponsored by University of California, Los Angeles.

RECRUITING
Registry status
NA
Development phase
30 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

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

Conditions Studied

Attention Deficit Hyperactivity Disorder Fetal Alcohol Spectrum Disorders

Interventions

  • DEVICE Trigeminal Nerve Stimulation (TNS)

Study Locations (1)

California

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

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2025-04-26
Est. Completion 2026-09-30
Phase NA
University of California, Los Angeles

897 total trials

What NCT06847165 shows while recruiting

NCT06847165 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 216-participant average among 102 other Attention Deficit Hyperactivity Disorder trials with a reported enrollment target (86% lower).

The record links to 2 conditions, with Attention Deficit Hyperactivity Disorder appearing as the primary indexed condition, and to 1 intervention - of which Trigeminal Nerve Stimulation (TNS) is the first listed.

NCT06847165 reports a single indexed study location in California.

Frequently Asked Questions

What is clinical trial NCT06847165 about?

NCT06847165 is a clinical study titled "Trigeminal Nerve Stimulation for Children With Prenatal Alcohol Exposure". 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 Administratio...

What is the current status of trial NCT06847165?

This trial is currently recruiting. It is a NA study. The enrollment target is 30 participants. The study started on 2025-04-26. Estimated completion is 2026-09-30.

What conditions does trial NCT06847165 study?

This clinical trial studies the following conditions: Attention Deficit Hyperactivity Disorder, Fetal Alcohol Spectrum Disorders.

What interventions are being tested in trial NCT06847165?

The interventions under investigation include: Trigeminal Nerve Stimulation (TNS) (DEVICE).

Who is sponsoring clinical trial NCT06847165?

This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06847165 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Attention Deficit Hyperactivity Disorder

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06847165's enrollment target sits among peer trials

30 81st of 102 higher than 14 of 102 other Attention Deficit Hyperactivity Disorder trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Attention Deficit Hyperactivity Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT06847165

Source: ClinicalTrials.gov NCT06847165, the US trial registry maintained by the National Library of Medicine. NCT06847165 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.