Researchers at UCLA Health are launching the first clinical trial to test whether a wearable device that delivers gentle nerve stimulation during sleep could ease ADHD symptoms in children with prenatal alcohol exposure.
Children exposed to alcohol in the womb have a heightened risk of developing ADHD-like symptoms including hyperactivity, impulsivity and executive function deficits such as difficulty paying attention, remembering, and organizing their behavior. Prenatal alcohol exposure affects about 5% of children in the U.S. with the majority developing these symptoms. These children are frequently less responsive to conventional pharmaceutical treatments for ADHD, such as psychostimulants, which can make the symptoms more disabling.
The two-year clinical trial, led by UCLA adjunct professor of child psychiatry Joseph O'Neill, will study whether a neurostimulation therapy may be an effective, at-home treatment option for these children.
Known as trigeminal nerve stimulation (TNS), the noninvasive therapy uses electrode patches attached to a small device that delivers gentle electric stimulation of the trigeminal nerve while the child sleeps. Parents place the electrode patches on the child's forehead before bed, with the device left on overnight. This stimulation activates brain regions associated with attention and executive function.
The U.S. Food and Drug Administration cleared the first external TNS device in 2019 after studies showed it safely improved ADHD symptoms in children ages seven to 12. However, its effectiveness for treating ADHD symptoms specifically for children with prenatal alcohol exposure has not been studied.
ADHD symptoms are highly disabling for children with prenatal alcohol exposure and difficult to manage for families. And these symptoms often fail to respond to standard treatment, such as drugs like methylphenidate, in children exposed to alcohol in the womb. There is a pressing need for expanded therapeutic options for these children. So, we are looking forward to testing this very safe novel therapy that has been effective in unexposed children with ADHD."
Joseph O'Neill, UCLA adjunct professor of child psychiatry
Funded by a $350,000 grant from the National Institutes of Alcohol Abuse and Alcoholism, the pilot clinical trial will involve 30 children ages eight to 12 with exposure to alcohol during gestation. Parents will be provided a Monarch eTNS device developed by the Los Angeles-based company NeuroSigma, Inc. to be used nightly for four weeks. The parents will keep track of the child's executive function, sleep habits, negative side effects and any adverse events. Both parents and children will rate tolerability as well as their satisfaction with treatment.
If the treatment is determined to be feasible and effective, the study would proceed to a randomized crossover clinical trial. The NIAAA is set to provide up to $2.1 million for the three-year trial.
"I am thrilled to be a part of this innovative study that I hope will provide relief for both children and their families who suffer from the negative consequences associated with prenatal alcohol exposure because these children have so much to offer to society," said study co-lead Mary O'Connor, professor emerita of psychiatry and biobehavioral sciences at the UCLA David Geffen School of Medicine.
The recruitment period for the trial is currently open. Interested families may contact the study by emailing [email protected], calling (310) 267-2710, or taking the online screener at https://bit.ly/TNS-PAE
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