Could a gentle forehead zap during sleep ease ADHD in kids with fetal alcohol exposure?

NCT ID NCT06847165

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Recruitment status, easiest to join first

Recruiting now This study
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Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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First seen Jul 16, 2026 · Last updated Jul 17, 2026 · Updated 1 time

Summary

This study tests whether a device that gently stimulates the forehead during sleep can help children aged 8 to 12 who have ADHD linked to prenatal alcohol exposure. The device, already cleared for general pediatric ADHD, is used at home by parents each night for four weeks. Researchers will check if it is safe, tolerable, and seems to work, and will use brain scans to understand how it affects the brain.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
trigeminal nerve stimulation (TNS) device that applies a weak electric current to the forehead during sleep
What this could lead to
If successful, this could offer a safe, at-home, non-drug option for managing ADHD symptoms in children with fetal alcohol spectrum disorders.
What could go wrong
This is a small pilot study with only 30 children, so results may not apply broadly. The treatment may not work for everyone, and side effects, though expected to be mild, are not fully known in this specific group.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

8 to 12 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * \- Fetal alcohol syndrome, partial fetal alcohol syndrome, or alcohol-related neurodevelopmental disorder per modified Institute of Medicine criteria (thus positive maternal drinking in pregnancy required, facial stigmata not required) * Prenatal alcohol exposure (PAE) \>6 drinks/week for \>= 2 weeks and/or \>= 3 drinks on \>= 2 occasions throughout gestation per Health Interview for Women/Health Interview for Adoptive and Foster Parents (HIW/HIAFP) * Diagnosis of Diagnostic and Statistical Manual 5th edition (DSM-5) attention deficit hyperactivity disorder (ADHD), including problems with inattention, hyperactivity, impulsivity, and/or executive function. Screening for ADHD will be done using the Swanson, Nolan, and Pelham Teacher and Parent Rating Scale (SNAP IV). Formal diagnosis of ADHD will be based on the Mini-International Neuropsychiatric Interview for Children and Adolescents (MINI-KID) with input from the Behavior Rating of Executive Function (BRIEF II) and the Conners 4. * Parent and child able to complete testing in English * Child able to cooperate during MRI * Full-Scale Intelligence Quotient \>70 per the Kaufman Brief Intelligence Test (K-BIT-2) * Child able to comply with study procedures * Age 8-12 Exclusion Criteria: * \- Other toxic exposure per HIW/HIAFP whose influence clearly surpasses that of alcohol (very rare) per study clinician judgement * Known genetic syndrome associated with ADHD-like symptoms including fragile X, tuberous sclerosis, or generalized resistance to thyroid hormone * Serious medical or neurologic illness likely to influence brain function, e.g., seizures, closed-head trauma * Gestation \< 34 weeks * Ferromagnetic metal, claustrophobia, or other MRI or TNS contraindication (e.g., insulin pumps or other body-worn devices) * Diagnosis of autism spectrum disorder, psychotic disorder, or major mood disorder * Active suicidal ideation as evidenced by meeting criteria for "Current" or "Lifetime attempt" on the Suicidality module or "Current' or 'In early remission' on the Suicide Behavior Disorder module of the MINI KID

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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How to take part

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Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

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

    RECRUITING

    Los Angeles, California, 90024, United States

    Contact Email: •••••@•••••

    Contact Email: •••••@•••••

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