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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 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 206-participant average among 88 other Attention Deficit Hyperactivity Disorder trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state.

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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.

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

Sponsor

University of California, Los Angeles

897 total trials

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What the Registry Record Tells You About NCT06847165

The ClinicalTrials.gov registry entry for NCT06847165 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 206-participant average among 88 other Attention Deficit Hyperactivity Disorder trials with a reported enrollment target (85% lower). The listed sponsor is University of California, Los Angeles, which has 897 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.