A new approach used to treat adults with medication-resistant depression and seizures has been found to be an effective and safe means of treatment for children with attention-deficit/ hyperactivity disorder (ADHD).
Researchers report that trigeminal nerve stimulation (TNS), currently used in Canada and Europe for depression and seizures, provides a non-medication treatment for ADHD. TNS utilizes a small stimulator worn on a child’s clothes to emit a low-level current, powered by a 9-volt battery.
Thin wires are connected to the device with an adhesive electrode patch worn across the forehead during sleep. Mild stimulation to the skin, barely or not perceptible to the child, activates deeper brain areas associated with concentration and impulse control. In the new study, children wore the patch an average of eight hours nightly and patches were removed each morning.
Study results are published the Journal of the American Academy of Child and Adolescent Psychiatry (JAACAP).
“ADHD is estimated to affect 9.5 percent of school-age children and 4.4 percent of adults,” said lead author James McGough, M.D., professor and child psychiatrist at the Semel Institute for Neuroscience and Human Behavior at the University of California, Los Angeles.
“Our current treatments mostly depend on medication with some role for behavioral therapies. Although there is great demand for non-medication ADHD treatments, the most popular options have minimal, if any, scientific evidence supporting their use.”
Investigators enrolled 62 children ages 8-12 years old and randomized them to receive active or sham TNS nightly for four weeks. Benefits in the active group were observed within the first week of treatment, with increasing improvement over the remaining weeks.
The size of treatment improvement was similar to that seen with FDA-approved nonstimulant ADHD medications.
In addition to reductions in behavioral ADHD symptoms, investigators found positive changes in brain activation with active TNS, measured by electroencephalography (EEG). This finding suggests measurable changes in neurological functioning in addition to behavioral improvement.
Researchers believe this could mean that TNS has beneficial effects by increasing activity in brain circuits that modulate hyperactivity and impulsivity.
A major limitation of many studies of non-medication ADHD treatments relates to difficulties maintaining effective blinding of the sham control condition. Investigators in this study demonstrated that after the initial week, parents of children in both active and sham TNS groups had equal expectation of benefit, suggesting that the study design successfully concealed which treatment children were receiving.
This result, in addition to differences in brain activation measured by EEG, further supports the study’s conclusion regarding the potential of TNS for ADHD therapy.
“I am excited that we found significant reductions in ADHD symptoms, as well as associated improvements in brain functioning, as a result of TNS therapy,” said McGough.
“Treatment was well accepted by patients and families, compliance was high, and there were no clinically important side effects. TNS has great potential as an additional option for managing ADHD.”