Could a gentle forehead zap during sleep ease ADHD in kids with fetal alcohol exposure?
NCT ID NCT06847165
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 Hide 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Attention deficit hyperactivity disorder are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The study's own enquiry address
This study publishes an address for enquiries. See it below .
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
By submitting, you agree to our Terms of use
Study contacts
-
Contact
Email: •••••@•••••
Locations
-
University of California Los Angeles Semel Institute Division of Child & Adolescent Psychiatry
RECRUITINGLos Angeles, California, 90024, United States
Contact Email: •••••@•••••
Contact Email: •••••@•••••
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Could hidden ADHD symptoms be dragging down medical Students' grades?
- Can virtual worlds teach Real-Life social skills to kids with ADHD?
- Disaster-Proofing ADHD: a parent training program to the test
- A drop of blood may reveal hidden prenatal alcohol exposure
- Can tailored school support boost behavior and language in kids with ADHD?
- Could piano practice sharpen the brains of children with FASD?