Fetal Alcohol Spectrum Disorders study: Trigeminal Nerve Stimulation
Official title Trigeminal Nerve Stimulation for Children With Prenatal Alcohol Exposure
ClinicalTrials.gov ID: NCT06847165
What this study is testing
- What it's testing
- The study will see if this trigeminal nerve stimulation is safe, tolerable, and shows early signs of helping these kids’ ADHD symptoms.
- Who it's for
- Children aged 8 to 12 who have ADHD that may be related to prenatal alcohol exposure.
- What's involved
- Parents will apply a small electric current to the child’s forehead each night for 8 hours while sleeping, for 4 weeks. The child will attend three clinic visits for screening, a pre‑treatment MRI, and a post‑treatment MRI, and will have a follow‑up phone call 4 weeks later.
- Time commitment
- The study lasts about 5 weeks, including three clinic visits (4‑5 hours, 2‑3 hours, 2‑3 hours) and nightly 8‑hour treatments at home.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 8 to 12
You may be able to join if
- \- Fetal alcohol syndrome, partial fetal alcohol syndrome, or alcohol-related neurodevelopmental disorder per modified Institute of Medicine criteria...
- Prenatal alcohol exposure (PAE) \>6 drinks/week for \>= 2 weeks and/or \>= 3 drinks on \>= 2 occasions throughout gestation per Health Interview for...
- Diagnosis of Diagnostic and Statistical Manual 5th edition (DSM-5) attention deficit hyperactivity disorder (ADHD), including problems with...
- Parent and child able to complete testing in English
- Child able to cooperate during MRI
You likely can't join if
- \- 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
See the full eligibility 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...
- 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.
- 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
- \- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Los Angeles, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 8 years to 12 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Los Angeles, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.