A new study suggests that trigeminal nerve stimulation (TNS), a noninvasive electrical stimulation treatment, may reduce symptoms of attention-deficit/hyperactivity disorder (ADHD) in children.
“Many parents are hesitant to give strong medications like stimulants to young children, so there has been a lot of interest from families in non-pharmacological alternatives for ADHD,” said lead study author James McGough, M.D., a professor of clinical psychiatry at the University of California, Los Angeles (UCLA).
The trigeminal nerve, the largest of the cranial nerves, connects sensory cells on the head with several brain regions involved in attention.
For the study, researchers at the David Geffen School of Medicine at the UCLA randomly assigned 62 children ages 8 to 12 with ADHD to receive four weeks of nightly stimulation with either a TNS device or sham device.
The research was designed to specifically test the effects of TNS, so all the children were medication-free during the study and at least 30 days prior.
The TNS and sham device looked the same — a small box with wires for placement on the forehead via an adhesive patch. The only difference was the sham devices produced no electric current.
While both groups of children experienced symptom improvements after one week, the children who received the active TNS showed continued improvements over the next three weeks. In contrast, symptoms among children in the placebo stimulation group plateaued after the first week.
At the end of four weeks, symptom scores in children in the TNS group dropped an average of 9 points (using the doctor-administered ADHD-Rating Scale) compared with a reduction of scores by about 4.5 points in children in the placebo group.
Overall, this 9-point reduction is less than what stimulants such as methylphenidate have shown in clinical studies, but is on par to nonstimulant medications used to treat children with ADHD, such as the norepinephrine reuptake inhibitor atomoxetine.
According to McGough, the differences seen between the two groups after the first week point to the improvements of TNS being more than just a placebo effect. But stronger validation came after analyzing electroencephalography (EEG) tests given to all the children.
“EEG measures brain wave activity, and our tests showed emphatic differences between the kids receiving active versus sham stimulation,” McGough said.
In fact, the brainwave changes found in children whose symptoms improved resembled those seen in people performing well on executive function tests, said McGough. This similarity supports the idea that the EEG changes represent changes in attention and decision-making.
McGough added that TNS was very well-tolerated. There were a few instances of headache or increased appetite among TNS users, but there were no serious side effects and no children had to quit treatment due to side effects.
The Food and Drug Administration is currently reviewing TNS as a treatment for pediatric ADHD. McGough noted that if approved, there can be more detailed discussions about where this approach might fit in the spectrum of available treatments.
He noted that more research is needed, particularly studies testing the long-term effects of TNS and studies assessing how TNS works in conjunction with medication.
The findings are published in the Journal of the American Academy of Child and Adolescent Psychiatry.
Source: American Psychiatric Association