In the Journals

Trigeminal nerve stimulation effective, safe for pediatric ADHD

Trigeminal nerve stimulation, or TNS, a minimal-risk noninvasive neuromodulation method, improved symptoms and brain functioning in children with ADHD in a blinded sham-controlled pilot study.

"ADHD is estimated to affect 9.5% of school-age children and 4.4% of adults," James McGough, MD, from the Semel Institute for Neuroscience and Human Behavior at University of California, Los Angeles, said in a press release. "Our current treatments mostly depend on medication with some role for behavioral therapies. Although there is great demand for nonmedication ADHD treatments, the most popular options have minimal, if any, scientific evidence supporting their use."

In the current study, researchers used resting-state quantitative electroencephalography (EEG) to determine the efficacy and safety of TNS for ADHD as well as potential changes in brain spectral power in 62 children aged 8 to 12 years.

Participants were randomly allocated to receive 4 weeks of active (120 Hz) or sham TNS, followed by 1 week without intervention. TNS was delivered at night during sleep. The stimulator was worn on the child’s pajamas and attached with wires to self-adhesive patch electrodes applied on the forehead to provide bilateral stimulation of V1 trigeminal branches for about 8 hours a night.

Clinicians evaluated ADHD Rating Scales (ADHD-RS) and Clinical Global Impression (CGI) scales weekly along with quantitative EEG at baseline and week 4.

In total, 32 children received active TNS and 30 received sham TNS. ADHD-RS total scores demonstrated a significant group-by-time interaction (F1228 = 8.12; P = .005), and the significant main effect of time (F1228 = 39.97; P < .0001) demonstrated improvement in both groups, with greater improvement with active TNS. Similarly, CGI-I scores favored active over sham TNS throughout the 4-week period (21168 = 8.75; P = .003), according to the results.

McGough and colleagues observed significant increases in weight and pulse in the active TNS group compared with the sham TNS group over 4 weeks; there were no serious adverse events reported in either group.

"Treatment was well accepted by patients and families, compliance was high and there were no clinically important side effects,” McGough said in the release. “TNS has great potential as an additional option for managing ADHD."

In addition, resting-state quantitative EEG indicated positive changes in brain activation with active TNS as shown by increased spectral power in the right frontal and frontal midline frequency bands.

“Although the present study finds that only slightly more than half of those receiving therapy have clinically meaningful improvement, the virtual lack of significant side effects should make it a popular treatment choice for many patients with ADHD, particularly for parents who prefer to avoid psychotropic medication,” the researchers wrote in the full study. – by Savannah Demko

Disclosures: McGough reports providing testimony on behalf of Janssen, Shire and Tris Pharmaceuticals. Please see the study for all other authors’ relevant financial disclosures.

Trigeminal nerve stimulation, or TNS, a minimal-risk noninvasive neuromodulation method, improved symptoms and brain functioning in children with ADHD in a blinded sham-controlled pilot study.

"ADHD is estimated to affect 9.5% of school-age children and 4.4% of adults," James McGough, MD, from the Semel Institute for Neuroscience and Human Behavior at University of California, Los Angeles, said in a press release. "Our current treatments mostly depend on medication with some role for behavioral therapies. Although there is great demand for nonmedication ADHD treatments, the most popular options have minimal, if any, scientific evidence supporting their use."

In the current study, researchers used resting-state quantitative electroencephalography (EEG) to determine the efficacy and safety of TNS for ADHD as well as potential changes in brain spectral power in 62 children aged 8 to 12 years.

Participants were randomly allocated to receive 4 weeks of active (120 Hz) or sham TNS, followed by 1 week without intervention. TNS was delivered at night during sleep. The stimulator was worn on the child’s pajamas and attached with wires to self-adhesive patch electrodes applied on the forehead to provide bilateral stimulation of V1 trigeminal branches for about 8 hours a night.

Clinicians evaluated ADHD Rating Scales (ADHD-RS) and Clinical Global Impression (CGI) scales weekly along with quantitative EEG at baseline and week 4.

In total, 32 children received active TNS and 30 received sham TNS. ADHD-RS total scores demonstrated a significant group-by-time interaction (F1228 = 8.12; P = .005), and the significant main effect of time (F1228 = 39.97; P < .0001) demonstrated improvement in both groups, with greater improvement with active TNS. Similarly, CGI-I scores favored active over sham TNS throughout the 4-week period (21168 = 8.75; P = .003), according to the results.

McGough and colleagues observed significant increases in weight and pulse in the active TNS group compared with the sham TNS group over 4 weeks; there were no serious adverse events reported in either group.

"Treatment was well accepted by patients and families, compliance was high and there were no clinically important side effects,” McGough said in the release. “TNS has great potential as an additional option for managing ADHD."

In addition, resting-state quantitative EEG indicated positive changes in brain activation with active TNS as shown by increased spectral power in the right frontal and frontal midline frequency bands.

“Although the present study finds that only slightly more than half of those receiving therapy have clinically meaningful improvement, the virtual lack of significant side effects should make it a popular treatment choice for many patients with ADHD, particularly for parents who prefer to avoid psychotropic medication,” the researchers wrote in the full study. – by Savannah Demko

Disclosures: McGough reports providing testimony on behalf of Janssen, Shire and Tris Pharmaceuticals. Please see the study for all other authors’ relevant financial disclosures.