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NCT06847165: TNS-PAE

Trigeminal Nerve Stimulation for Children With Prenatal Alcohol Exposure

Recruiting now NA Last updated 1 July 2025
What this trial tests

NA trial testing Trigeminal Nerve Stimulation (TNS) in Fetal Alcohol Spectrum Disorders in 30 participants. Currently enrolling.

Timeline
26 April 2025
Primary endpoint
30 September 2026
30 September 2026

Quick facts

Lead sponsorUniversity of California, Los Angeles
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment30
Start date26 April 2025
Primary completion30 September 2026
Estimated completion30 September 2026
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of California, Los Angeles

Who can join

Adults 8 to 12, any sex, with Fetal Alcohol Spectrum Disorders or Attention Deficit Hyperactivity Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Trigeminal nerve stimulation (TNS) for children with attention deficit/hyperactivity disorder and fetal alcohol spectrum disorder: Feasibility study protocol.
    O'Neill J, Joshi S, Alger JR, Leuchter AF, et al · · 2025 · PMID 40880352 · DOI 10.1371/journal.pone.0330986
  2. Trigeminal Nerve Stimulation (TNS) for Children with Attention Deficit/Hyperactivity Disorder and Fetal Alcohol Spectrum Disorder: Feasibility Study Protocol
    O’Neill J, Joshi S, Alger JR, Schneider BN, et al · · 2025 · DOI 10.1101/2025.07.07.25331025

Verify or expand the search:

Other trials of Trigeminal Nerve Stimulation (TNS)

Trials testing the same drug.

Other recruiting trials for Fetal Alcohol Spectrum Disorders

Currently open trials in the same condition.

Other University of California, Los Angeles trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06847165.

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