Trigeminal Nerve Stimulation for Children With Prenatal Alcohol Exposure
Recruiting
N/A
Interventional Study
Fetal Alcohol Spectrum Disorders
Attention Deficit Hyperactivity Disorder
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 8 – 12
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 30 (estimated)
- Sponsor
- University of California, Los Angeles · Other
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About This Trial
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 specificall…
Trial Locations
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Eligibility Criteria
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 dri…
Contacts