Researchers in the US 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 organising their behaviour.
Prenatal alcohol exposure affects about 5 per cent of children in the US 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.
O’Neill said: “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.”
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.
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 randomised crossover clinical trial.
The NIAAA is set to provide up to $2.1 million for the three-year trial.
Study co-lead Mary O’Connor is professor emerita of psychiatry and biobehavioural sciences at the UCLA David Geffen School of Medicine.
She said: “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.”
