Noninvasive therapy seeks to enhance focus and behavior by gently stimulating a nerve associated with attention and executive functioning.
Researchers at UCLA Health are initiating the first clinical trial to determine whether a wearable device that provides gentle nerve stimulation during sleep can help reduce ADHD symptoms in children who were exposed to alcohol before birth.
Prenatal alcohol exposure significantly increases the risk of developing ADHD-like symptoms, including hyperactivity, impulsivity, and executive function difficulties such as problems with attention, memory, and behavioral organization. About 5% of children in the U.S. are affected by prenatal alcohol exposure, and a majority of them develop these cognitive and behavioral challenges. Importantly, these children often respond poorly to standard ADHD treatments, such as psychostimulant medications, making their symptoms harder to manage.
The two-year study, led by Dr. Joseph O’Neill, an adjunct professor of child psychiatry at UCLA, will evaluate whether this neurostimulation therapy could offer an effective, at-home alternative for managing symptoms in this vulnerable population.
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.
Addressing an Urgent Need for New Treatment Options
“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,” O’Neill said. “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.”
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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